Prescription drug · ANDA
Isosorbide (isosorbide dinitrate) NDC 68001-375
Isosorbide dinitrate 20 mg/1 · Tablet · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-375-00 | 68001037500 | 100 TABLET in 1 BOTTLE, PLASTIC (68001-375-00)Marketed from Nov 30, 2018 |
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
- Generic name (nonproprietary)
- isosorbide dinitrate
- Active ingredients
- Isosorbide dinitrate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088088
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 68001-375_9498fa14-1614-4a8e-b872-41c11745b01eSPL ID 9498fa14-1614-4a8e-b872-41c11745b01eSPL set ID 9498fa14-1614-4a8e-b872-41c11745b01eRxCUI 206842, 314055, 381056UNII IA7306519NUPC 0368001375009, 0368001374002, 0368001373005
- 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
N468001037500followed by a unit qualifier and the quantityPackage 68001-0375-00. 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, USP 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 088088
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 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7991 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7990 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-148 |
| Isosorbide Dinitrate | Isosorbide dinitrate 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-147 |
| Isosorbide Dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-149 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6619 |
| Isosorbide Dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6620 |
| Isosorbide Dinitrate | Isosorbide dinitrate 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1769 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1771 |
| Isosorbide Dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1772 |