What this pack is
NITROSTAT is the brand name in this record; nitroglycerin sublingual tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
NITROSTATGeneric namenitroglycerin sublingual tablets
How this medicine works
Nitroglycerin generates nitric-oxide-related signalling, activates guanylate cyclase and increases cyclic GMP, relaxing vascular smooth muscle. Venodilation can reduce venous return and cardiac workload, while arterial dilation can reduce resistance. This explains headache, dizziness and hypotension and why PDE-5 inhibitors or sGC stimulators that amplify the pathway are contraindicated. It cannot be used to calculate an individual's tablet count.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More 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
- NITROSTAT
- Source-scoped market brand names
- NITROSTAT · United StatesCurrent regulator record ↗NDA 021134; 0.3/0.4/0.6 mg are prescription RLD products and 0.6 mg is also the RS; three current 100-tablet package panels are recorded separately.
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
- nitroglycerin sublingual tablets
- Dosage-form class
- Nitroglycerin sublingual tablets: 0.3, 0.4 or 0.6 mg per tablet; dissolve under the tongue or in the buccal pouch rather than swallowing like a conventional tablet; keep in the original glass bottle and tightly recap after every use
- Route
- Sublingual or buccal dissolution (higher-risk emergency product-identity field; not gastrointestinal administration)
- 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.
3 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 · U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)
Nitroglycerin 0.3 mg per tablet; original 100-tablet glass bottle/carton
- Product code
- NDC 58151-309-01
- Form and route
- NITROSTAT nitroglycerin sublingual tablet · sublingual or buccal dissolution (not a conventional swallowed tablet)
- Container
- original 100-tablet glass bottle and carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- nitroglycerin
- 0.3 mglabel strength per tablet; not an individual's tablet count, frequency, emergency-use count or course
- Package
- 100 tablets per bottle
- Labelled appearance
- white; purple strength band on carton · white, round, flat-faced sublingual tablet · imprint N / 3Appearance clue only; not a splitting instruction
United States label · U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)
Nitroglycerin 0.4 mg per tablet; original 100-tablet glass bottle/carton
- Product code
- NDC 58151-310-01
- Form and route
- NITROSTAT nitroglycerin sublingual tablet · sublingual or buccal dissolution (not a conventional swallowed tablet)
- Container
- original 100-tablet glass bottle and carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- nitroglycerin
- 0.4 mglabel strength per tablet; not an individual's tablet count, frequency, emergency-use count or course
- Package
- 100 tablets per bottle
- Labelled appearance
- white; teal strength band on carton · white, round, flat-faced sublingual tablet · imprint N / 4Appearance clue only; not a splitting instruction
United States label · U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)
Nitroglycerin 0.6 mg per tablet; original 100-tablet glass bottle/carton
- Product code
- NDC 58151-311-01
- Form and route
- NITROSTAT nitroglycerin sublingual tablet · sublingual or buccal dissolution (not a conventional swallowed tablet)
- Container
- original 100-tablet glass bottle and carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- nitroglycerin
- 0.6 mglabel strength per tablet; not an individual's tablet count, frequency, emergency-use count or course
- Package
- 100 tablets per bottle
- Labelled appearance
- white; red strength band on carton · white, round, flat-faced sublingual tablet · imprint N / 6Appearance clue only; not a splitting instruction
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
NITROSTAT label reading: this is a sublingual tablet, not a conventional swallowed 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.
The 0.3, 0.4 and 0.6 mg figures are strengths per tablet. The label says to place a tablet under the tongue or in the buccal pouch and allow it to dissolve; do not crush, chew or swallow it. All three strengths must remain in the original glass container and be tightly capped immediately after each use to prevent loss of potency. This page identifies the product and does not create anyone's chest-pain action count.
- Check the route first: NITROSTAT dissolves under the tongue or in the buccal pouch. Swallowing, crushing or chewing departs from the label. A small tablet does not permit adding 0.3, 0.4 and 0.6 mg figures or choosing a tablet count yourself.
- New, different, severe or persistent chest pain may be an emergency. Follow the established emergency plan and contact local emergency services immediately; do not wait for a website, online advice or a self-chosen strength change.
- The label contraindicates PDE-5 inhibitors such as sildenafil, tadalafil, vardenafil and avanafil, and soluble guanylate cyclase stimulators, because severe hypotension may occur. Even when products were not taken on the same day, a clinician or pharmacist must review the exact product and timing; this site does not calculate a safe interval.
- Older adults and people with low blood pressure, dehydration, antihypertensives, diuretics, alcohol or other vasodilators need particular review for dizziness, weakness, syncope and falls. Fainting, altered awareness or severe weakness requires prompt help.
- No burning or tingling in the mouth does not prove failure of release, and a headache does not prove authenticity or justify self-adding a tablet. Use the exact pack, expiry, original-container storage, prescription and professional assessment.
- Tightly recap the original glass bottle immediately after each use. Do not transfer tablets to a pill organiser, plastic bag or a mixed container. Ask a pharmacist about travel storage, expiry or a bottle left open; appearance or tingling cannot establish potency.
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 · 2026-08-29
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 · 2
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): U.S. Viatris NDA brand label for NITROSTAT nitroglycerin sublingual tablets (updated 15 Feb 2023; package records published in 2024) ↗Current regulatory record · reviewed 2026-08-29
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 · 2026-08-29FDA Drugs@FDA: current NITROSTAT NDA 021134 application, RLD and RS records ↗reviewed 2026-08-29
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 NITROSTAT (nitroglycerin sublingual tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
NITROSTAT is the brand in this record and nitroglycerin sublingual tablets is the active-ingredient name. Check both with the dosage form (Nitroglycerin sublingual tablets: 0.3, 0.4 or 0.6 mg per tablet; dissolve under the tongue or in the buccal pouch rather than swallowing like a conventional tablet; keep in the original glass bottle and tightly recap after every use) 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): U.S. Viatris NDA brand label for NITROSTAT nitroglycerin sublingual tablets (updated 15 Feb 2023; package records published in 2024) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current NITROSTAT NDA 021134 application, RLD and RS records ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How nitroglycerin works: nitric-oxide-related signalling relaxes vascular smooth muscle
- ‘Sublingual’ describes the route and onset design, not a larger amount. Swallowed, patch, spray, ointment and intravenous products have different product boundaries and cannot be self-substituted from a shared ingredient or milligrams.
- Blood-pressure reduction, dehydration, alcohol and other vasodilating or antihypertensive medicines may have additive effects. This site does not use one blood-pressure reading to decide continuation, addition or stopping.
- This mechanism does not create a routine whole-genome-screening requirement for everyone. Testing decisions depend on the clinical situation, medicine list, blood pressure and relevant conditions.
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): U.S. Viatris NDA brand label for NITROSTAT nitroglycerin sublingual tablets (updated 15 Feb 2023; package records published in 2024) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current NITROSTAT NDA 021134 application, RLD and RS records ↗reviewed 2026-08-29
- FDA: NITROSTAT NDA 021134 reformulated sublingual-tablet approval letter (1 May 2000) ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
NITROSTATnitroglycerin sublingual tablets
This page includes an exact current U.S. public-label package panel for NITROSTAT, 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 stated in the current label
This is the historical field in the current label; it is not the NDA 021134 reformulation approval date.
DailyMed (NLM): U.S. Viatris NDA brand label for NITROSTAT nitroglycerin sublingual tablets (updated 15 Feb 2023; package records published in 2024) ↗FDA approved the NDA 021134 reformulation
The approval covers 0.3, 0.4 and 0.6 mg sublingual tablets; review records describe improvements in weight control, content uniformity and physical stability.
FDA: NITROSTAT NDA 021134 reformulated sublingual-tablet approval letter (1 May 2000) ↗Current label revision and package publication
The DailyMed label was revised in Feb 2023, and three Viatris 100-tablet package records were published in 2024.
DailyMed (NLM): U.S. Viatris NDA brand label for NITROSTAT nitroglycerin sublingual tablets (updated 15 Feb 2023; package records published in 2024) ↗
MARKET SCOPE
Market-record boundary
United States
Current prescription RLD sublingual tablets; 0.6 mg is RSThree original 100-tablet glass-bottle/carton panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility or an individual's emergency plan.
Mainland China, EU, Japan and other markets
Current market records not establishedNo local approval, package, supply or interchangeability is inferred from a U.S. brand, shared ingredient or mg figure.
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.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Is a NITROSTAT tablet swallowed or placed under the tongue?
This NITROSTAT dossier covers a sublingual tablet. The label says to place it under the tongue or in the buccal pouch and let it dissolve; do not crush, chew or swallow it. Do not transfer this instruction to another nitroglycerin form.
Can the tablets be moved into a weekly pill organiser?
The label says to keep the tablets in the original glass container and tightly cap it immediately after use to prevent loss of potency. Do not mix them with routine medicines; ask a pharmacist about carrying and replacement using the actual bottle.
Can NITROSTAT be used after sildenafil or tadalafil?
Current labelling contraindicates PDE-5 inhibitors with NITROSTAT because severe hypotension may occur. Do not calculate a safe interval yourself. During chest pain, contact emergency services and report the exact product, amount and time taken.
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.