Prescription drug · NDA
Nitrostat (nitroglycerin) NDC 63187-884
Nitroglycerin .4 mg/1 · Tablet · Sublingual · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-884-25 | 63187088425 | 25 TABLET in 1 BOTTLE (63187-884-25)Marketed from Oct 2, 2017 |
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)
- Nitrostat
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — .4 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021134
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 63187-884_3195d486-86b4-4ee4-b049-a1ad55e9ab06SPL ID 3195d486-86b4-4ee4-b049-a1ad55e9ab06SPL set ID 6fe3965f-0dd8-4bae-9771-de25074cb1b0RxCUI 198039, 207346UNII G59M7S0WS3
- 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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463187088425followed by a unit qualifier and the quantityPackage 63187-0884-25. 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)
INDICATIONS AND USAGE Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021134
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 |
|---|---|---|---|---|
| Nitrostatnitroglycerin tablet | Nitroglycerin .4 mg/1 | TabletSublingual | Henry Schein, Inc. | 0404-9800 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-7203 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Mylan Pharmaceuticals Inc. | 59762-0489 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Mylan Pharmaceuticals Inc. | 59762-3304 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Mylan Pharmaceuticals Inc. | 59762-4921 |
| Nitrostatnitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-309 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-310 |
| Nitrostatnitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-311 |