Prescription drug · NDA AUTHORIZED GENERIC
Nitroglycerin NDC 59762-0489
Nitroglycerin .6 mg/1 · Tablet · Sublingual · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0489-1 | 59762048901 | 1 BOTTLE, GLASS in 1 CARTON (59762-0489-1) / 100 TABLET in 1 BOTTLE, GLASSMarketed from Aug 26, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — .6 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021134
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 59762-0489_2ac009f2-257f-4603-a1e8-c50aa9e31f4bSPL ID 2ac009f2-257f-4603-a1e8-c50aa9e31f4bSPL set ID 041f127e-5166-4484-bc1a-0a373d1187aeRxCUI 198038, 198039, 198040UNII 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
N459762048901followed by a unit qualifier and the quantityPackage 59762-0489-01. 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 sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin sublingual tablets are a nitrate vasodilator indicated for 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 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 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Proficient Rx LP | 63187-884 |
| 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 |