Prescription drug · ANDA
Isosorbide dinitrate NDC 70771-1503
Isosorbide dinitrate 20 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1503-0 | 70771150300 | 1000 TABLET in 1 BOTTLE (70771-1503-0)Marketed from Nov 25, 2019 | |
| 70771-1503-1 | 70771150301 | 100 TABLET in 1 BOTTLE (70771-1503-1)Marketed from Nov 25, 2019 |
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)
- Isosorbide dinitrate
- Generic name (nonproprietary)
- isosorbide dinitrate
- Active ingredients
- Isosorbide dinitrate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213057
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 70771-1503_3b64c3fa-5b13-4c53-96e1-221685297680SPL ID 3b64c3fa-5b13-4c53-96e1-221685297680SPL set ID 5b0db8af-bcf9-458f-b752-420130cba428RxCUI 197839, 197840, 206842, 314055, 381056UNII IA7306519N
- 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
N470771150300followed by a unit qualifier and the quantityPackage 70771-1503-00. 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 Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213057
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 |
|---|---|---|---|---|
| Isosorbide dinitrate | Isosorbide dinitrate 40 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1152 |
| Isosorbide dinitrate | Isosorbide dinitrate 30 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1151 |
| Isosorbide dinitrate | Isosorbide dinitrate 5 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1148 |
| Isosorbide dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1149 |
| Isosorbide dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1150 |
| Isosorbide dinitrate | Isosorbide dinitrate 30 mg/1 | TabletOral | BluePoint Laboratories | 68001-562 |
| Isosorbide dinitrate | Isosorbide dinitrate 30 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1504 |
| Isosorbide dinitrate | Isosorbide dinitrate 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1501 |
| Isosorbide dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1502 |
| Isosorbide dinitrate | Isosorbide dinitrate 40 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1505 |
| Isosorbide dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Northstar Rx LLC | 16714-008 |
| Isosorbide dinitrate | Isosorbide dinitrate 5 mg/1 | TabletOral | Northstar Rx LLC | 16714-007 |
| Isosorbide dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Northstar Rx LLC | 16714-009 |
| Isosorbide dinitrate | Isosorbide dinitrate 30 mg/1 | TabletOral | Northstar Rx LLC | 16714-010 |