Prescription drug · ANDA
Nitroglycerin NDC 68462-639
Nitroglycerin .4 mg/1 · Tablet · Sublingual · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-639-01 | 68462063901 | 1 BOTTLE in 1 CARTON (68462-639-01) / 100 TABLET in 1 BOTTLEMarketed from Sep 19, 2017 | |
| 68462-639-45 | 68462063945 | 4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25)Marketed from Sep 19, 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)
- Nitroglycerin
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — .4 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206391
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 68462-639_76e69387-efc6-4816-972c-765cb260b34aSPL ID 76e69387-efc6-4816-972c-765cb260b34aSPL set ID fa789d65-9407-4965-bd06-4457444b42beRxCUI 198038, 198039, 198040UNII G59M7S0WS3UPC 0368462638019, 0368462639016, 0368462640012
- 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
N468462063901followed by a unit qualifier and the quantityPackage 68462-0639-01. 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 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 ANDA 206391
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 |
|---|---|---|---|---|
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Proficient Rx LP | 82804-122 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Glenmark Pharmaceuticals Inc., USA | 68462-638 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Glenmark Pharmaceuticals Inc., USA | 68462-640 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-6818 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | NuCare Pharmaceuticals, Inc. | 68071-3773 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | ProPharma Distribution | 84549-639 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Medical Purchasing Solutions, LLC | 71872-7033 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2910 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | HF Acquisition Co LLC, DBA HealthFirst | 51662-1445 |