What this pack is
APRESOLINE / hydralazine is the brand name in this record; hydralazine hydrochloride immediate-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
APRESOLINE / hydralazineGeneric namehydralazine hydrochloride immediate-release tablets
How this medicine works
The current label says hydralazine acts directly on vascular smooth muscle, producing peripheral vasodilation and reduced peripheral resistance. Heart rate, cardiac output, renin and aldosterone may also increase. This does not reduce the full molecular mechanism to one switch or predict an individual's pressure, pulse, benefit or risk.
Read source: United States ↗Current regulatory record · reviewed 2026-09-02More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- APRESOLINE / hydralazine
- Source-scoped market brand names
- APRESOLINE · United StatesHistorical regulator record ↗Historical originator/RLD under NDA 008303. The 10, 25, 50 and 100 mg oral tablets are currently DISCN and marked as not withdrawn for safety or effectiveness. This page does not display a historical original-brand pack.
- hydralazine hydrochloride tablets · United StatesCurrent regulator record ↗Current Strides generic label under ANDA 200770; 10, 25, 50 and 100 mg, each in 100-, 500- and 1000-tablet bottles. A regulatory label is not live stock.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- hydralazine hydrochloride immediate-release tablets
- Dosage-form class
- Hydralazine hydrochloride immediate-release oral tablets. Products outside this oral-tablet identity include the 20 mg/mL injection, the BIDIL isosorbide dinitrate/hydralazine hydrochloride fixed combination and other antihypertensives. Historical originator APRESOLINE and current generic tablets also remain separate. A shared ingredient, purpose or milligram figure does not establish conversion, tablet count, frequency, titration, splitting or substitution.
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
12 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed generic label (2026)
10 mg hydralazine hydrochloride per tablet; 100-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-733-06
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 100 tablets per bottle
- Labelled appearance
- orange · round, biconvex immediate-release tablet · imprint 10Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
10 mg hydralazine hydrochloride per tablet; 500-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-733-07
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 500 tablets per bottle
- Labelled appearance
- orange · round, biconvex immediate-release tablet · imprint 10Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
10 mg hydralazine hydrochloride per tablet; 1000-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-733-08
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 1000 tablets per bottle
- Labelled appearance
- orange · round, biconvex immediate-release tablet · imprint 10Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
25 mg hydralazine hydrochloride per tablet; 100-tablet bottle
- Product code
- NDC 64380-734-06
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 25 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 100 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 25Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
25 mg hydralazine hydrochloride per tablet; 500-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-734-07
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 25 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 500 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 25Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
25 mg hydralazine hydrochloride per tablet; 1000-tablet bottle
- Product code
- NDC 64380-734-08
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 25 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 1000 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 25Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
50 mg hydralazine hydrochloride per tablet; 100-tablet bottle
- Product code
- NDC 64380-735-06
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 50 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 100 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 50Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
50 mg hydralazine hydrochloride per tablet; 500-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-735-07
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 50 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 500 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 50Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
50 mg hydralazine hydrochloride per tablet; 1000-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-735-08
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 50 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 1000 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 50Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
100 mg hydralazine hydrochloride per tablet; 100-tablet bottle
- Product code
- NDC 64380-736-06
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 100 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 100 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 100Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
100 mg hydralazine hydrochloride per tablet; 500-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-736-07
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 100 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 500 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 100Unscored; no permission to split it yourself is established
United States label · Current U.S. DailyMed generic label (2026)
100 mg hydralazine hydrochloride per tablet; 1000-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-736-08
- Form and route
- hydralazine hydrochloride immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- hydralazine hydrochloride
- 100 mglabelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive
- Package
- 1000 tablets per bottle
- Labelled appearance
- orange · round, flat bevel-edged immediate-release tablet · imprint 100Unscored; no permission to split it yourself is established
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
Hydralazine enlarged label: per-tablet mg, bottle count, orthostatic hypotension, chest pain and lupus-like reactions
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The 10, 25, 50 and 100 mg figures are amounts per tablet; 100, 500 and 1000 Tablets are bottle counts. The current label describes these tablets as unscored, so arithmetic or appearance cannot create permission to split. The site also does not turn professional dose-adjustment text into an individual's frequency, tablet count, titration or missed-dose plan.
- Dizziness, darkening vision on standing, marked weakness, palpitations or syncope may accompany low blood pressure. Older adults, people at higher fall risk or those using other antihypertensives require timely review of the complete medicine list. Severe syncope, injury or altered awareness needs local emergency care.
- Hydralazine can cause myocardial stimulation, tachycardia and angina; the label links it to myocardial ischaemia and notes implication in myocardial infarction. New or worsening chest pain, marked breathlessness, cold sweat or radiating pain must not wait for a webpage and requires local emergency care.
- Longer treatment can cause a syndrome resembling systemic lupus erythematosus, including glomerulonephritis. Joint pain, fever, chest pain, marked malaise, rash or urinary/kidney changes need treating-team review. Periodic complete blood count and antinuclear antibody testing described by the label belongs to the responsible team; the site does not order tests.
- Numbness, tingling or burning can suggest peripheral neuritis. The label also lists reduced haemoglobin/red cells, leucopenia, agranulocytosis or purpura. Progressive neurological symptoms, fever/sore throat, unusual bleeding or bruising needs prompt medical review.
- Give the doctor or pharmacist the complete list, including other antihypertensives, diuretics, beta blockers, nitrates, BIDIL, PDE-5 inhibitors and monoamine oxidase inhibitors. Do not self-combine, space, remove a pack or change use from one blood-pressure reading.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-02
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. generic hydralazine hydrochloride 10/25/50/100 mg label, twelve bottle NDCs and four exact package panels (ANDA 200770; 2026 label) ↗Current regulatory record · reviewed 2026-09-02
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-09-02FDA Drugs@FDA: 1953 initial approval, four historical oral-tablet RLD strengths and DISCN status for APRESOLINE / hydralazine hydrochloride NDA 008303 ↗reviewed 2026-09-02
- FDA · United States · Regulatory product record or label archive · 2026-09-02FDA: historical APRESOLINE (hydralazine hydrochloride) oral-tablet label under NDA 008303 (1996 version) ↗reviewed 2026-09-02
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about APRESOLINE / hydralazine (hydralazine hydrochloride immediate-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
APRESOLINE / hydralazine is the brand in this record and hydralazine hydrochloride immediate-release tablets is the active-ingredient name. Check both with the dosage form (Hydralazine hydrochloride immediate-release oral tablets. Products outside this oral-tablet identity include the 20 mg/mL injection, the BIDIL isosorbide dinitrate/hydralazine hydrochloride fixed combination and other antihypertensives. Historical originator APRESOLINE and current generic tablets also remain separate. A shared ingredient, purpose or milligram figure does not establish conversion, tablet count, frequency, titration, splitting or substitution.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. generic hydralazine hydrochloride 10/25/50/100 mg label, twelve bottle NDCs and four exact package panels (ANDA 200770; 2026 label) ↗Current regulatory record · reviewed 2026-09-02
- FDA Drugs@FDA: 1953 initial approval, four historical oral-tablet RLD strengths and DISCN status for APRESOLINE / hydralazine hydrochloride NDA 008303 ↗reviewed 2026-09-02
- FDA: historical APRESOLINE (hydralazine hydrochloride) oral-tablet label under NDA 008303 (1996 version) ↗reviewed 2026-09-02
HOW IT WORKS · NOT A TREATMENT PLAN
How hydralazine affects blood pressure: direct vascular smooth-muscle relaxation with reflex responses
- Vasodilation does not permit self-assembling hydralazine with isosorbide dinitrate, BIDIL, nitroglycerin, a calcium-channel blocker or another antihypertensive by milligrams. A shared blood-pressure role may add hypotension, heart-rate and fall risks.
- Hydralazine has polymorphic acetylation, and slow acetylators may have higher drug levels. This explains some variability but is not a default reason for the site to recommend whole-genome screening, genotype testing or self-adjustment.
- The same per-tablet milligram figure has different context across disease, age, liver/kidney status, pressure, pulse and co-medication. The site identifies the exact product and label boundary and does not calculate an individual target pressure, equivalent dose or titration speed.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. generic hydralazine hydrochloride 10/25/50/100 mg label, twelve bottle NDCs and four exact package panels (ANDA 200770; 2026 label) ↗Current regulatory record · reviewed 2026-09-02
- FDA Drugs@FDA: 1953 initial approval, four historical oral-tablet RLD strengths and DISCN status for APRESOLINE / hydralazine hydrochloride NDA 008303 ↗reviewed 2026-09-02
- FDA: historical APRESOLINE (hydralazine hydrochloride) oral-tablet label under NDA 008303 (1996 version) ↗reviewed 2026-09-02
SOURCE-TRACEABLE ARCHIVE
APRESOLINE / hydralazinehydralazine hydrochloride immediate-release tablets
This page includes an exact current U.S. public-label package panel for APRESOLINE / hydralazine, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval of APRESOLINE
FDA Drugs@FDA records NDA 008303 as a priority-reviewed new molecular entity initially approved in 1953.
FDA Drugs@FDA: 1953 initial approval, four historical oral-tablet RLD strengths and DISCN status for APRESOLINE / hydralazine hydrochloride NDA 008303 ↗Historical FDA oral-tablet label version
FDA publicly preserves a 1996 APRESOLINE oral-tablet label under NDA 008303. It supports history and is not presented as current brand supply.
FDA: historical APRESOLINE (hydralazine hydrochloride) oral-tablet label under NDA 008303 (1996 version) ↗Current originator status and generic-pack verification
All four APRESOLINE oral RLD strengths are DISCN and not withdrawn for safety or effectiveness. The current ANDA 200770 label lists twelve generic bottle NDCs.
FDA Drugs@FDA: 1953 initial approval, four historical oral-tablet RLD strengths and DISCN status for APRESOLINE / hydralazine hydrochloride NDA 008303 ↗
MARKET SCOPE
Market-record boundary
United States — APRESOLINE oral tablets
Historical originator/RLD; discontinuedNDA 008303; the 10, 25, 50 and 100 mg rows are DISCN and not withdrawn for safety or effectiveness.
United States — current generic
Current public generic labelANDA 200770; 10, 25, 50 and 100 mg, each in 100-, 500- and 1000-tablet bottles.
Injection and BIDIL
Separate dosage form or fixed combinationAPRESOLINE 20 mg/mL injection is not an oral tablet. BIDIL additionally contains isosorbide dinitrate and cannot be merged into these packs from a shared hydralazine ingredient.
Markets outside the United States
Local brand, strength, pack and supply are not establishedCheck the local regulator, current label and pack in hand item by item.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Is the pictured bottle the original APRESOLINE product?
No. The image is a current Strides generic package panel under ANDA 200770. APRESOLINE is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand.
Does 1000 Tablets mean taking 1000 tablets at once?
No. 1000 Tablets is the bottle count; 10/25/50/100 mg is the labelled amount per tablet. The site does not use a bottle count or milligrams to generate an individual tablet count, frequency or titration plan.
Can a 100 mg tablet be split into two 50 mg halves?
Not from arithmetic alone. The current label describes these tablets as unscored, and 100 mg and 50 mg remain separate exact products. Splitting requires the exact prescription, current manufacturer label and pharmacist review.
Are APRESOLINE, BIDIL and ISORDIL the same medicine?
No. APRESOLINE is the historical hydralazine brand; BIDIL is a fixed isosorbide dinitrate/hydralazine hydrochloride combination; ISORDIL is an isosorbide dinitrate product. A shared cardiovascular role does not permit substitution or combination.
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