Prescription drug · NDA AUTHORIZED GENERIC
Nitroglycerin Lingual (nitroglycerin) NDC 28595-120
Nitroglycerin 400 ug/1 · Spray · Oral · Allegis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 28595-120-49 | 28595012049 | 1 BOTTLE in 1 CARTON (28595-120-49) / 60 SPRAY in 1 BOTTLEMarketed from Jul 1, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nitroglycerin Lingual
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 400 ug/1
- Dosage form
- Spray
- Route
- Oral
- Labeler
- Allegis Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018705
- Marketing start
- Marketing end
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 28595-120_462b36d0-0a1e-bda8-e063-6294a90a5792SPL ID 462b36d0-0a1e-bda8-e063-6294a90a5792SPL set ID fadd07b7-189b-4678-ad0f-bf1e4d3d1300RxCUI 705129UNII G59M7S0WS3UPC 0328595120126
- Pharmacologic class
- Nitrate Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N428595012049followed by a unit qualifier and the quantityPackage 28595-0120-49. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin Lingual Spray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018705
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nitrolingualnitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | INDEPENDENCE PHARMACEUTICALS, LLC | 21724-100 |
| Nitroglycerin Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1519 |
| Nitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | Prasco Laboratories | 66993-241 |
| Nitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1672 |