Prescription drug · NDA AUTHORIZED GENERIC
isosorbide mononitrate NDC 67046-1577
Isosorbide mononitrate 10 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1577-3 | 67046157703 | 30 TABLET in 1 BLISTER PACK (67046-1577-3)Marketed from Sep 4, 2025 |
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 mononitrate
- Generic name (nonproprietary)
- isosorbide mononitrate
- Active ingredients
- Isosorbide mononitrate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020215
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 67046-1577_3dffc7eb-52db-f691-e063-6294a90a9354SPL ID 3dffc7eb-52db-f691-e063-6294a90a9354SPL set ID 3dffc84e-93e4-0005-e063-6294a90aa9caRxCUI 311192UNII LX1OH63030
- 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
N467046157703followed by a unit qualifier and the quantityPackage 67046-1577-03. 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 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 NDA 020215
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 20 mg/1 | TabletOral | Proficient Rx LP | 63187-900 |
| isosorbide mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Coupler LLC | 67046-1578 |
| isosorbide mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-102 |
| isosorbide mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-103 |
| isosorbide mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | Lannett Company, Inc. | 62175-106 |
| isosorbide mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Lannett Company, Inc. | 62175-107 |