Prescription drug · ANDA
Isosorbide dinitrate NDC 16714-010
Isosorbide dinitrate 30 mg/1 · Tablet · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-010-01 | 16714001001 | 100 TABLET in 1 BOTTLE (16714-010-01)Marketed from May 1, 2020 |
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)
- Isosorbide dinitrate
- Generic name (nonproprietary)
- isosorbide dinitrate
- Active ingredients
- Isosorbide dinitrate — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northstar Rx LLC
- 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 16714-010_be0de7ff-f8d9-472f-a35c-252a2cf16954SPL ID be0de7ff-f8d9-472f-a35c-252a2cf16954SPL set ID 246c749d-aa28-44ce-8d42-984660afff2aRxCUI 197839, 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
N416714001001followed by a unit qualifier and the quantityPackage 16714-0010-01. 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)
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 20 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1503 |
| 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 |