Prescription drug · ANDA
Isosorbide Mononitrate NDC 64950-251
Isosorbide mononitrate 20 mg/1 · Tablet · Oral · Genus Lifesciences Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-251-01 | 64950025101 | 100 TABLET in 1 BOTTLE (64950-251-01)Marketed from Apr 9, 2026 |
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 Mononitrate
- Generic name (nonproprietary)
- isosorbide mononitrate
- Active ingredients
- Isosorbide mononitrate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Genus Lifesciences Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075037
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 64950-251_74da603c-8c7e-4823-a2a7-82e6ae007531SPL ID 74da603c-8c7e-4823-a2a7-82e6ae007531SPL set ID 0d739bf3-0672-4504-9064-b39d6b200b47RxCUI 311192, 311197UNII LX1OH63030UPC 0364950250015, 0364950251012
- 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
N464950025101followed by a unit qualifier and the quantityPackage 64950-0251-01. 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 mononitrate tablets, USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate 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 075037
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 Mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | Genus Lifesciences Inc. | 64950-250 |
| Isosorbide Mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2620 |
| Isosorbide Mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2631 |