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Nitroglycerin .6 mg Tablet, 100-count — NDC 43598-0437-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nitroglycerin .6 mg Tablet, 100-count — NDC 43598-437-01 (Billing 43598-0437-01)

by Dr. Reddys Laboratories Inc · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Nitroglycerin .6 mg Tablet from Dr. Reddys Laboratories Inc, marketed since Aug 2016 and currently FDA-listed; retail pharmacies pay about $0.0843 per tablet (NADAC). It is this product's only package size.

NDC 43598-0437-01
🏷️ FDA NDC (as labeled) 43598-437-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Nitroglycerin (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0791-2026
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0324-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0331-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-437-01
Product NDC 43598-437
11-digit billing NDC 43598043701
NCPDP billing unit EA — each (per item)
RxCUI 198038, 198039, 198040
UNII G59M7S0WS3
UPC 0343598437019, 0343598436357, 0343598436012
Application # ANDA208191
SPL Set ID c555f8de-477f-0225-98a2-baf8945bbd63
Established class (EPC) Nitrate Vasodilator
Physiologic effect Vasodilation
Chemical class Nitrates
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-29
Route SUBLINGUAL
Dosage form TABLET
Substance NITROGLYCERIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 32100030000720
GPI class Nitroglycerin
GCN Seq No 000476
GCN 01773
HICL code 000159
Ingredient (HICL) Nitroglycerin
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A7
Therapeutic class — intermediate (HIC2) Vasoactive Drugs
HIC3 code A7B
Therapeutic class — specific (HIC3) Vasodilators,Coronary
AHFS code 24:08.08.00
AHFS class Nitrates And Nitrites
FDB label name NITROGLYCERIN 0.6 MG TABLET SL
FDB brand name Nitroglycerin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000476
  • GCN: 01773
  • GPI-14 (Medi-Span): 32100030000720
  • HICL (First Databank): 000159
  • AHFS class code: 24:08.08.00
  • RxCUI (RxNorm): 198038
Why two NDCs? The FDA registers this code as 43598-437-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43598-0437-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nitrate Vasodilator class.

Pharmacologic class Nitrate Vasodilator
Drug family (ATC) Organic nitrates, Muscle relaxants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name NITROGLYCERIN 0.6 MG TABLET SL Ingredient Nitroglycerin
📗 Our plain-language guide HelloPharmacist
  • It is mainly used to relieve or prevent angina, which is chest pain from coronary artery disease. Rectal ointment treats chronic anal fissure pain, and IV forms are used in hospita...
  • Use your spray or tablet at the first sign of an attack, ideally sitting down. You can repeat it about every 5 minutes, up to three doses in 15 minutes. If the pain continues or fe...
  • How do I use it during an angina attack?
  • Headache is the most common one, and it often eases with continued use. You may also feel lightheaded. Sit down if you feel dizzy, and call for help if you faint or feel very weak,...
📖 Read our full Nitroglycerin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.084 $8.43 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1595 $15.95 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Mar 2021 Jan 2026 May 2026 Sep 2026 $0.303 $0.072
▼ Down 72% over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43598-0437-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2016-08-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nitroglycerin .6 mgthis 43598-0437-01 Dr. 100 tablets $0.084 AB Availability likely —
Nitroglycerin .6 mg 59651-0659-00 Aurobindo 100 tablets $0.084 AB Availability likely —
Nitroglycerin .6 mg 59762-0489-01 Mylan 100 tablets $0.084 AB Availability likely —
Nitroglycerin .6 mg 68462-0640-01 Glenmark 100 tablets $0.084 AB Availability likely —
Nitroglycerin .6 mg 69339-0175-01 Natco 1 tablet $0.084 AB Availability likely —
nitroglycerin .6 mg 70756-0016-11 Lifestar 100 tablets $0.084 AB Availability likely —
Nitroglycerin .6 mg 72888-0140-01 Advagen 100 tablets $0.084 AB Availability likely —
Nitroglycerin .6 mg 43547-0987-04 Solco 100 tablets — AB FDA listed —
Nitrostat .6 mg 58151-0311-01 Viatris 100 tablets — AB FDA listed —
Nitroglycerin .6 mg 60429-0841-01 Golden 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRectangle
ImprintCL;6
Size4 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDr. Reddys Laboratories Inc
Application holderDR REDDYS LABORATORIES INC
FDA applicationANDA208191 (ANDA)
Labeler code43598
First marketedAug 2016
Product typeHuman Prescription Drug
Portfolio33 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 47 words ▾

1 INDICATIONS AND USAGE Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (1)

⏱️ Dosage and Administration 213 words ▾

2 DOSAGE AND ADMINISTRATION Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered every 5 minutes until relief is obtained.

No more than three tablets are recommended within a 15-minute period. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention. Nitroglycerin may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet. Administer nitroglycerin at rest, preferably in the sittingposition. • At the onset of an attack, administer one tablet under the tongue or buccal pouch. One additional tablet may be administered every 5 minutes as needed.

No more than 3 total tablets are recommended within a 15 minute period. (2) • If chest pain persists after three tablets, seek prompt medical attention. (2) • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

(2)

💊 Dosage Forms and Strengths 123 words ▾

3 DOSAGE FORMS & STRENGTHS Nitroglycerin is supplied as white, round, flat-faced tablets in three strengths: 0.3 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "3" on the other side and are supplied in bottles of 100 tablets. 0.4 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "4" on the other side and are supplied in bottles of 25 and 100 tablets. 0.6 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "6" on the other side and are supplied in bottles of 100 tablets.

Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg (3)

⛔ Contraindications 205 words ▾

4 CONTRAINDICATIONS • Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. (4.1, 7.1) • Severe anemia (4.2) • Increased intracranial pressure (4.3) • Hypersensitivity to nitroglycerin or to other nitrates or nitrites or any excipient (4.4) • Circulatory failure and shock (4.5)

4.1PDE-5-Inhibitors and sGC-Stimulators Do not use nitroglycerin in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)]. Do not use nitroglycerin in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension.

4.2Severe Anemia Nitroglycerin is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia).

4.3Increased Intracranial Pressure Nitroglycerin may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury).

4.4Hypersensitivity Nitroglycerin is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient.

4.5Circulatory Failure and Shock Nitroglycerin is contraindicated in patients with acute circulatory failure or shock.

⚠️ Warnings and Cautions 167 words ▾

5 WARNINGS AND PRECAUTIONS • Tolerance: Excessive use may lead to tolerance. (5.1) • Hypotension: Severe hypotension may occur. (5.2)

5.1Tolerance Excessive use may lead to the development of tolerance. Only the smallest dose required for effective relief of the acute angina attack should be used. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.

5.2Hypotension Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume- depleted, or are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Symptoms of severe hypotension (nausea, vomiting, weakness, pallor, perspiration and collapse/syncope) may occur even with therapeutic doses.

5.3Hypertrophic Obstructive Cardiomyopathy Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

5.4Headache Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persist but usually subside with continued use.

🤒 Adverse Reactions 132 words ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail elsewhere in the label: • Hypotension [see Warnings and Precautions (5.2)] • Headache [see Warnings and Precautions (5.4)] • Hypersensitivity [see Contraindications (4.4)] Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses.

Syncope due to nitrate vasodilatation has been reported. Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy. Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 187 words ▾

7 DRUG INTERACTIONS Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2) Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2)

7.1PDE-5-Inhibitors and sGC-Stimulators Nitroglycerin is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Nitroglycerin is contraindicated in patients who are taking soluble guanylate cyclase (sGC) stimulators.

Concomitant use can cause hypotension. The time course and dose dependence of these interactions have not been studied, and use within a few days of one another is not recommended. Appropriate supportive care for the severe hypotension has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

7.2Ergotamine Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris.Therefore, patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk summary Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk ofmajor birth defects or miscarriage. In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data No embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 80 and 240 mg/kg/day, respectively, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day from gestation day 7-17, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day from gestation day 6-18.

8.2Lactation Risk summary Sublingual nitroglycerin has not been studied in lactating women. It is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production.

8.4Pediatric Use The safety and effectiveness of nitroglycerin in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of nitroglycerin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~1 min read ▾

10 OVERDOSE

10.1Signs and Symptoms, Methemoglobinemia Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions, and possibly death due to circulatory collapse.

Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.

10.2Treatment of Overdosage As hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. No specific antagonist to the vasodilator effects of nitroglycerin is known. Keep the patient recumbent in a shock position and comfortably warm.

Passive movement of the extremities may aid venous return. Intravenous infusion of normal saline or similar fluid may also be necessary. Administer oxygen and artificial ventilation, if necessary.

If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required unless the patient is known to have G-6-PD deficiency. If an excessive quantity of nitroglycerin has been recently swallowed gastric lavage may be of use. As epinephrine is ineffective in reversing the severe hypotensive events associated with overdosage, it is not recommended for resuscitation.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.

12.2Pharmacodynamics The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of postcapillary vessels, including large veins, promotes peripheral pooling of blood, decreases venous return to the heart, and reduces left ventricular end-diastolic pressure (preload).Nitroglycerin also produces arteriolar relaxation, thereby reducing peripheral vascular resistance and arterial pressure (afterload), and dilates large epicardial coronary arteries; however, the extent to which this latter effect contributes to the relief of exertional angina is unclear.

Therapeutic doses of nitroglycerin may reduce systolic, diastolic, and mean arterial blood pressure. Effective coronary perfusion pressure is usually maintained, but can be compromised if blood pressure falls excessively, or increased heart rate decreases diastolic filling time. Elevated central venous and pulmonary capillary wedge pressures, and pulmonary and systemic vascular resistance are also reduced by nitroglycerin therapy.

Heart rate is usually slightly increased, presumably due to a compensatory response to the fall in blood pressure. Cardiac index may be increased, decreased, or unchanged. Myocardial oxygen consumption or demand (as measured by the pressure-rate product, tension- time index, and stroke-work index) is decreased and a more favorable supply-demand ratio can be achieved.

Patients with elevated left ventricular filling pressures and increased systemic vascular resistance in association with a depressed cardiac index are likely to experience an improvement in cardiac index. In contrast, when filling pressures and cardiac index are normal, cardiac index may be slightly reduced following nitroglycerin administration. Consistent with the symptomatic relief of angina, digital plethysmography indicates that onset of the vasodilatory effect occurs approximately 1 to 3 minutes after sublingual nitroglycerin administration and reaches a maximum by 5 minutes postdose.

Effects persist for at least 25 minutes following nitroglycerin administration.

12.3Pharmacokinetics Absorption Nitroglycerin is rapidly absorbed following sublingual administration of nitroglycerin tablets. Mean peak nitroglycerin plasma concentrations occur at a mean time of approximately 6 to 7 minutes postdose (Table 1). Maximum plasma nitroglycerin concentrations (C max ) and area under the plasma concentration- time curves (AUC) increase dose-proportionally following 0.3 to 0.6 mg nitroglycerin.

The absolute bioavailability of nitroglycerin from nitroglycerin sublingualtablets is approximately 40% but tends to be variable due to factors influencing drug absorption, such as sublingual hydration and mucosal metabolism. Parameter Mean Nitroglycerin (SD) Values 2Χ 0.3 mg Nitroglycerin Tablets 1Χ 0.6 mg NitroglycerinTablets C max , ng/mL 2.3 (1.7) 2.1 (1.5) T max , min 6.4 (2.5) 7.2 (3.2) AUC(0–¥), min 14.9 (8.2) 14.9 (11.4) t½, min 2.8 (1.1) 2.6 (0.6) Distribution The volume of distribution (V Area ) of nitroglycerin following intravenous administration is

3.3L/kg. At plasma concentrations between 50 and 500 ng/mL, the binding of nitroglycerin to plasma proteins is approximately 60%, while that of 1,2- and 1,3-dinitroglycerin is 60% and 30%, respectively. Metabolism A liver reductase enzyme is of primary importance in the metabolism of nitroglycerin to glycerol di- and mononitrate metabolites and ultimately to glycerol and organic nitrate. Known s… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 174 words ▾

16 HOW SUPLIED/STORAGE AND HANDLING Nitroglycerin is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. 0.3 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "3" on the other side and are supplied in bottles of 100 tablets. Bottle of 100 NDC 43598-435-01 0.4 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "4" on the other side and are supplied in bottles of 25 and 100 tablets.

Bottle of 100 NDC 43598-436-01 Convenience Package NDC 43598-436-11 0.6 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "6" on the other side and are supplied in bottles of 100 tablets. Bottle of 100 NDC 43598-437-01 Store at Controlled Room Temperature 20°C–25°C (68°F–77°F) [see USP Controlled room temperature].

📋 Description 65 words ▾

11 DESCRIPTION Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is: Molecular weight: 227.09

💬 Information for Patients 39 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Rx only Manufactured by: Ingenus Pharmaceuticals NJ, LLCFairfield, NJ 07004, USA Manufactured for: Dr. Reddy’s Laboratories Inc. Princeton, New Jersey 08540, USA Revised: 09/2022

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal carcinogenesis studies with sublingually administered nitroglycerin have not been performed. Carcinogenicity potential of nitroglycerin was evaluated in rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years. Rats developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes.

At high dose, the incidences of hepatocellular carcinomas in males was 48% and in females was 33%, compared to 0% in untreated controls. Incidences of testicular tumors were 52% vs. 8% in controls.

Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice. Nitroglycerin was mutagenic in Ames tests performed in 2 different laboratories. Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, PO, or in ex vivo cytogenetic tests in rat and dog cells.

In a 3-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for 6 months prior to mating of the F0 generation, with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen.

Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high- dose males. In this 3-generation study, there was no clear evidence of teratogenicity.

📄 Patient Package Insert ~3 min read ▾

Nitroglycerin Sublingual Tablets, USP (nahy-truh-glis-er-in) Read this information carefully before you start nitroglycerin sublingual tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor.

If you have any questions about nitroglycerin , ask your doctor. Your doctor will know if nitroglycerin sublingual tablet is right for you. What is nitroglycerin?

Nitroglycerin is a type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina. What is Angina?

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back.

Nitroglycerin sublingual tablets can relieve this pain. Who should not use nitroglycerin sublingual tablets? Do not use nitroglycerin sublingual tablets if you are allergic to organic nitrates (like the active ingredient in nitroglycerin sublingual tablets) .

You should not take nitroglycerin sublingual tablets if you have the following conditions: very recent heart attack severe anemia increased pressure in the head Do not take nitroglycerin sublingual tablets with drugs for erectile dysfunction, like VIAGRA ® (sildenafil citrate), CIALIS ® (tadalafil), or LEVITRA ® (vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure. Do not take nitroglycerin sublingual tablets if you take medicines called guanylate cyclase stimulators which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

What should I tell my doctor before taking nitroglycerin sublingual tablets? Before using nitroglycerin sublingual tablets , tell your doctor if: You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat. You are taking any medicines that reduce blood pressure.

You are taking any diuretics (water pills). You are taking medications to treat depression or psychiatric illness. You are taking ergotamine or similar drugs for migraine headaches.

You are taking aspirin. You are taking the blood thinner medicine heparin. You are taking any medicines for erectile dysfunction.

You are pregnant or plan to become pregnant. You are breastfeeding. How should I take nitroglycerin sublingual tablets?

Do not chew, crush, or swallow nitroglycerin sublingual tablets. You should sit down when taking nitroglycerin sublingual tablets and use caution when you stand up. This eliminates the possibility of falling due to lightheadedness or dizziness.

One tablet should be dissolved under the tongue or in the oral cavity at the first sign of chest pain. The dose may be repeated approximately every 5 minutes, until the chest pain is relieved. If the pain persists after a total of 3 tablets in a 15-minute, period, or is different than you typically experience, call your doctor or seek emergency help.

Nitroglycerin sublingual tablets may be used 5 to 10 minutes prior to activities that might cause chest pain. You may feel a burning or tingling sensation in your mouth when you take nitroglycerin sublingual tablets . What should I avoid while taking nitroglycerin sublingual tablets?

Do not breastfeed. It is not known if nitroglycerin will pass through your milk. Do not consume alcohol while taking nitroglycerin sublingual tablets , as this can lower your blood pressure.

Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first. What are the possible side effects of nitroglycerin sublingual tablets? Nitroglycerin may cause the following side effects: headache vertigo (a major symptom of balance disorder) dizziness weakness heart palpitations (unusual awareness of the heartbeat) low blood pressure upon rising from a seat… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 58 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION 0.3 mg : Container Label: 100's

0.3 mg: Container Carton Label: 100's

0.4 mg: Container Label: 25's

0.4 mg : Container Carton Label: 4 x 25's count

0.6 mg : Container Label: 100's

0.6 mg: Container Carton Label: 100's

0.4 mg: Container Label : 100's

0.4 mg : Container Carton Label: 100's

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nitroglycerin — the program that covers self-administered drugs. 16 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nitroglycerin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.16M
Claims incl. refills
600.2K
Beneficiaries
480.2K
Spend / beneficiary
$17.00
Spend / claim
$13.60
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.