What this pack is
CAPOTEN is the brand name in this record; captopril is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
CAPOTENGeneric namecaptopril
Mainland China pack-name cue开博通Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The FDA label describes captopril as an angiotensin-converting-enzyme (ACE) inhibitor. ACE helps convert angiotensin I to angiotensin II, which constricts blood vessels and stimulates aldosterone secretion. Inhibiting this pathway helps explain why blood pressure, vascular resistance and potassium-related monitoring matter, but does not predict individual response or determine an amount.
Read source: United States ↗Current regulatory record · reviewed 2026-08-28More 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.
- Mainland China pack-name cue
- 开博通
- International brand name
- CAPOTEN
- Generic name
- captopril
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
Mainland China trade-name search cue:开博通. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
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.
5 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 · FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)
Captopril 12.5 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)
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
- NDA 018343 historical label text identity; exact NDC/package panel not established
- Form and route
- CAPOTEN captopril scored oral tablet · oral (historical-label product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-28; actual marketing, stock and availability are not established.
- captopril
- 12.5 mghistorical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction
United States label · FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)
Captopril 25 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)
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
- NDA 018343 historical label text identity; exact NDC/package panel not established
- Form and route
- CAPOTEN captopril scored oral tablet · oral (historical-label product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-28; actual marketing, stock and availability are not established.
- captopril
- 25 mghistorical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction
United States label · FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)
Captopril 50 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)
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
- NDA 018343 historical label text identity; exact NDC/package panel not established
- Form and route
- CAPOTEN captopril scored oral tablet · oral (historical-label product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-28; actual marketing, stock and availability are not established.
- captopril
- 50 mghistorical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction
United States label · FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)
Captopril 100 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)
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
- NDA 018343 historical label text identity; exact NDC/package panel not established
- Form and route
- CAPOTEN captopril scored oral tablet · oral (historical-label product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-28; actual marketing, stock and availability are not established.
- captopril
- 100 mghistorical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction
CN · Historical pack example in Shenzhen market-regulator standard DB4403/T 140—2021; not a current approval or supply finding
Kaibotong captopril tablets: 12.5 mg per tablet, 20-tablet pack (historical 2021 official-standard example)
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
- Current approval number not established from the cited official standard
- Form and route
- Kaibotong captopril tablet (historical pack cue) · oral (historical pack-text cue)
- Listing review
- Cited product evidence reviewed 2026-08-28; actual marketing, stock and availability are not established.
- captopril
- 12.5 mgamount per tablet shown on a historical pack; not an individual tablet count or current-product finding
- Package
- 20 tablets per pack (historical example)
PACKAGE-VISUAL STATUS
Historical CAPOTEN label and Chinese pack cues were reviewed, but no official image matching a current original-brand pack was retained, so no package visual is shown
The current FDA application record marks CAPOTEN brand strengths discontinued; the 2015 historical label provides text identities for four scored tablets, and a 2021 Shenzhen market-regulator standard provides a historical Kaibotong 12.5 mg × 20-tablet pack example. To avoid presenting a historical illustration, retail image, current generic pack or another manufacturer's image as current CAPOTEN original-brand appearance, the dossier withholds package imagery and retains source, text identity and historical boundaries.
LABEL READING · NOT A PRESCRIPTION
CAPOTEN/captopril label reading: separate the historical brand, generic name and milligrams per tablet
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.
This module separates the FDA historical original-brand CAPOTEN label, a current generic captopril label and the historical Chinese Kaibotong pack cue. 12.5, 25, 50 and 100 mg are strengths per tablet, not personal tablet counts generated by the site; brand discontinuation does not mean every captopril product is discontinued.
- Read the whole pack first: CAPOTEN/Kaibotong are historical brand cues and captopril is the generic name. Also check market, strength per tablet, whether it is a combination, the current label and prescription. Do not treat a captopril combination or another ACE inhibitor as the same product.
- The 12.5, 25, 50 and 100 mg figures state captopril per tablet; they cannot be converted into a tablet count without the prescription, kidney function, blood pressure, electrolytes, other medicines and timing.
- A score in the historical label does not mean every currently marketed captopril tablet may be self-split, or that half a tablet suits an individual. Check the exact manufacturer and label in hand and confirm with a pharmacist or clinician.
- Put pain medicines (especially NSAIDs), diuretics, potassium supplements or potassium-containing salt substitutes, other blood-pressure medicines and all OTC products on one list. The FDA historical label warns that older, volume-depleted or renally impaired people using an NSAID with an ACE inhibitor may have worsened kidney function; the site cannot replace item-by-item interaction review.
- Swelling of the face, lips, tongue or throat, or breathing/swallowing difficulty may be serious angioedema. Use local emergency services immediately; do not wait for a webpage decision or self-redose/switch.
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 checkFDA · United States · Regulatory product record or label archive · 2026-08-28
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 routeFDA: 2015 historical U.S. prescribing information for CAPOTEN (captopril) ↗Historical public record · reviewed 2026-08-28
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 · 2026-08-28FDA Drugs@FDA: current CAPOTEN (captopril) NDA 018343 application record ↗Current regulatory record · reviewed 2026-08-28
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-28DailyMed (NLM): current U.S. generic captopril public label (Hikma; updated 27 Dec 2024; ANDA) ↗Current regulatory record · reviewed 2026-08-28
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 CAPOTEN (captopril). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
CAPOTEN is the brand in this record and captopril is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) 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.
- FDA: 2015 historical U.S. prescribing information for CAPOTEN (captopril) ↗Historical public record · reviewed 2026-08-28
- FDA Drugs@FDA: current CAPOTEN (captopril) NDA 018343 application record ↗Current regulatory record · reviewed 2026-08-28
- DailyMed (NLM): current U.S. generic captopril public label (Hikma; updated 27 Dec 2024; ANDA) ↗Current regulatory record · reviewed 2026-08-28
HOW IT WORKS · NOT A TREATMENT PLAN
How captopril works: ACE inhibition reduces formation of angiotensin II
- Being blood-pressure medicines does not make captopril self-combinable, alternate-day interchangeable or milligram-convertible with lisinopril, valsartan, losartan, sacubitril/valsartan or a diuretic combination.
- Mechanism terms such as ACE, renin and aldosterone do not replace professional review of blood pressure, kidney function, electrolytes and the complete medicine list, and are not a reason for self-stopping or increasing.
- Persistent cough, dizziness, weakness, urine change or another new symptom needs review in the context of the exact product and individual. Face/tongue/throat swelling, breathing trouble, fainting or another severe acute problem requires immediate local emergency support.
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.
- FDA Drugs@FDA: current CAPOTEN (captopril) NDA 018343 application record ↗Current regulatory record · reviewed 2026-08-28
- FDA: 2015 historical U.S. prescribing information for CAPOTEN (captopril) ↗Historical public record · reviewed 2026-08-28
- DailyMed (NLM): current U.S. generic captopril public label (Hikma; updated 27 Dec 2024; ANDA) ↗Current regulatory record · reviewed 2026-08-28
- Shenzhen Administration for Market Regulation: historical 12.5 mg × 20-tablet package cue for captopril tablets (Kaibotong), DB4403/T 140—2021 ↗Historical public record · reviewed 2026-08-28
SOURCE-TRACEABLE ARCHIVE
CAPOTENcaptopril
This page links to public primary-source material for CAPOTEN. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approved the original CAPOTEN NDA 018343
Current FDA Drugs@FDA application data link CAPOTEN, captopril, NDA 018343 and the ORIG 1 approval node dated 6 Apr 1981. This establishes U.S. original-brand history; it does not automatically establish approval, branding, packaging, supply or interchangeability in Mainland China or another market.
FDA Drugs@FDA: current CAPOTEN (captopril) NDA 018343 application record ↗Historical CAPOTEN label lists four scored oral-tablet strengths
The FDA 2015 historical label lists 12.5, 25, 50 and 100 mg scored oral tablets and explicitly warns that the document may not be the latest approved label. The dossier uses it as a dated label-reading record, not a current supply or package finding.
FDA: 2015 historical U.S. prescribing information for CAPOTEN (captopril) ↗Current generic captopril label updated
The current Hikma captopril label on DailyMed was updated 27 Dec 2024 and is marketed under an ANDA. It supports current ingredient, strength, warning and interaction reading without treating a generic pack as CAPOTEN original-brand packaging.
DailyMed (NLM): current U.S. generic captopril public label (Hikma; updated 27 Dec 2024; ANDA) ↗
MARKET SCOPE
Market-record boundary
United States
Original-brand history verified; CAPOTEN strengths are marked discontinued in the current FDA recordThe current FDA application record also retains the statement that discontinuation was not for safety or effectiveness reasons. This dossier links the NDA history and 2015 historical label and separately lists a current generic label; it does not present the historical brand as currently stocked, purchasable or individually suitable.
Mainland China
Historical Kaibotong 12.5 mg × 20-tablet pack cue onlyA 2021 Shenzhen market-regulator standard lists it as a confusing-package example. The material supports checking the name, strength per tablet, pack count and historical manufacturer wording; it does not establish a current approval number, holder, supply, originator/generic relationship, authenticity or interchangeability.
European Union, Japan and other markets
Current market record not establishedNo local brand, approval, package, supply, sale eligibility or interchangeability is inferred from U.S. CAPOTEN history, the captopril generic name, shared ACE-inhibitor mechanism or the historical Chinese pack.
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
Does CAPOTEN discontinuation mean captopril can no longer be used?
No. The current FDA record describes the marketing status of U.S. CAPOTEN brand strengths and says discontinuation was not for safety or effectiveness reasons; DailyMed still provides a current generic captopril label. Existence, approval, supply and individual suitability require separate checking for the target market and exact product.
If the tablet is scored, can it simply be split to make half an amount?
The site cannot make that individual decision. The score in the historical CAPOTEN label describes that historical product; the manufacturer, dosage form, strength, purpose of the score, prescription and individual context for the product in hand all need checking. Do not use a historical brand label or web image to decide splitting for another current manufacturer's product.
Can captopril be used with ibuprofen, a diuretic, valsartan or potassium on the medicine list?
The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, potassium-containing salt substitutes, kidney function, electrolytes and blood pressure need review together by a pharmacist or prescriber; do not self-combine, stop, separate or substitute.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.