Nitroglycerin .4 mg Tablet, 100-count
Other active recalls for Nitroglycerin (different manufacturers) — 3 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nitrate Vasodilator class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). It is also used just before activities that may cause episodes of angina in order to prevent the angina from occurring. Nitroglycerin is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.
Read the full MedlinePlus article ↗- Great question — it's actually the same active ingredient, just in very different forms for very different places. The tablets, sprays, patches, and capsules all work by widening b...
- What's the difference between nitroglycerin for chest pain and the kind used for anal fissure pain?
- No — this is one of the most important safety warnings with nitroglycerin. Both drugs work on the same pathway, and combining them can cause a sudden, severe drop in blood pressure...
- Can I use nitroglycerin if I take sildenafil (Viagra) or tadalafil (Cialis)?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nitroglycerin — tap one for details:
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💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
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UNII Z82Y2C65EA
Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nitroglycerin .4 mg 43598-0436-01 | Dr. | 100 tablets | $0.084 | AB | Availability likely | — |
| Nitroglycerin .4 mg 59651-0658-00 | Aurobindo | 100 tablets | $0.084 | AB | Availability likely | — |
| Nitroglycerin .4 mg 59762-3304-01 | Mylan | 100 tablets | $0.084 | AB | Availability likely | — |
| Nitroglycerin .4 mg 68462-0639-01 | Glenmark | 100 tablets | $0.084 | AB | Availability likely | — |
| Nitroglycerin .4 mg 69339-0174-01 | Natco | 100 tablets | $0.084 | AB | Availability likely | — |
| Nitroglycerin .4 mg 72888-0139-01 | Advagen | 100 tablets | $0.084 | AB | Availability likely | — |
| Nitroglycerin .4 mg 43547-0986-04 | Solco | 100 tablets | $0.128 | AB | Availability likely | — |
| nitroglycerin .4 mg 70756-0014-02 | Lifestar | 100 tablets | $0.128 | AB | Availability likely | — |
| nitroglycerin .4 mg 72603-0266-04 | NorthStar | 100 tablets | $0.128 | AB | Availability likely | — |
| Nitrostat .4 mg 00404-9800-01 | Henry | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 50090-3266-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 50090-6818-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Nitrostat .4 mg 50090-7203-00 | A-S | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 51662-1282-01 | HF | 25 tablets | — | AB | Discontinued | — |
| Nitroglycerin .4 mg 51662-1676-03 | HF | 600 tablets | — | AB | FDA listed | — |
| Nitrostat .4 mg 58151-0310-01 | Viatris | 100 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mgthis 60429-0840-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Nitrostat .4 mg 63187-0884-25 | Proficient | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 67296-2177-02 | Redpharm | 100 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 68071-2941-05 | NuCare | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 68071-3773-05 | NuCare | 100 tablets | — | AB | FDA listed | — |
| nitroglycerin .4 mg 70518-4277-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 71205-0225-25 | Proficient | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 71872-7010-01 | Medical | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 71872-7033-01 | Medical | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 71872-7300-01 | Medical | 25 tablets | — | AB | FDA listed | — |
| nitroglycerin .4 mg 71872-7338-01 | Medical | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 71872-7368-01 | Medical | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 82804-0077-25 | Proficient | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 82804-0122-25 | Proficient | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 84549-0639-45 | ProPharma | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 85766-0116-00 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 70518-2910-00 | REMEDYREPACK | 25 tablets | — | AB | FDA listed | — |
| nitroglycerin .4 mg 67296-2313-02 | Redpharm | 25 tablets | — | AB | FDA listed | — |
| Nitroglycerin .4 mg 51662-1445-03 | HF | 600 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60429-0840-01 You're viewing this | 100 TABLET in 1 BOTTLE (60429-840-01) | 2016-09-12 | Active |
| 60429-0840-04 | 4 BOTTLE in 1 CARTON (60429-840-04) / 25 TABLET in 1 BOTTLE | 2016-09-12 | Active |
Pack size FAQ
What quantity is in NDC 60429-0840-01?
What is the difference between NDC 60429-0840-01 and NDC 60429-0840-04?
What NDC number is used to bill for this package of Nitroglycerin .4 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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…
📦 How Supplied / Storage and Handling ▾
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 60429-839-01 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 60429-840-01 Convenience Package NDC 60429-840-04 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 60429-841-01 Store at Controlled Room Temperature 20°C–25°C (68°F–77°F) [see USP Controlled room temperature].
📋 Description ▾
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 structure
💬 Information for Patients ▾
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 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA