Prescription drug · NDA AUTHORIZED GENERIC
isosorbide mononitrate NDC 81665-103
Isosorbide mononitrate 20 mg/1 · Tablet · Oral · OMNIVIUM PHARMACEUTICALS LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81665-103-10 | 8166501031081665010310 | 100 TABLET in 1 BOTTLE (81665-103-10)Marketed from May 2, 2024 |
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
- OMNIVIUM PHARMACEUTICALS LLC.NDC labeler code 81665
- 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 81665-103_dba5d0c5-88bc-4091-b882-43dddc70923eSPL ID dba5d0c5-88bc-4091-b882-43dddc70923eSPL set ID cdf01e14-778b-4b3f-8372-1c18f266fb98RxCUI 311192, 311197UNII LX1OH63030UPC 0381665103108
- 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
N481665010310followed by a unit qualifier and the quantityPackage 81665-0103-10. 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.
About NDC 81665-103
- What is NDC 81665-103?
- 81665-103 is the product NDC for isosorbide mononitrate, Isosorbide mononitrate 20 mg/1 tablet, listed with the FDA by OMNIVIUM PHARMACEUTICALS LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- isosorbide mononitrate.
- What is the active ingredient?
- Isosorbide mononitrate.
- Who is the labeler?
- OMNIVIUM PHARMACEUTICALS LLC., NDC labeler code 81665. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for isosorbide mononitrate?
- 61 other product NDCs are listed under this name. See all isosorbide mononitrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other isosorbide mononitrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isosorbide Mononitrate | Isosorbide mononitrate 120 mg/1 | Tablet, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-161 | 11788-0161-01 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-159 | 11788-0159-0111788-0159-0511788-0159-10 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-160 | 11788-0160-0111788-0160-0511788-0160-10 |
| Isosorbide Mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | Coupler LLC | 67046-1687 | 67046-1687-03 |
| Isosorbide Mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Genus Lifesciences Inc. | 64950-251 | 64950-0251-01 |
| Isosorbide Mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | Genus Lifesciences Inc. | 64950-250 | 64950-0250-01 |
| Isosorbide Mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-252 | 62559-0252-01 |
| Isosorbide Mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-253 | 62559-0253-01 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1632 | 67046-1632-03 |
| isosorbide mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Coupler LLC | 67046-1578 | 67046-1578-03 |
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 10 mg/1 | TabletOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-102 |
| isosorbide mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Coupler LLC | 67046-1578 |
| isosorbide mononitrate | Isosorbide mononitrate 10 mg/1 | TabletOral | Coupler LLC | 67046-1577 |
| 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 |
| isosorbide mononitrate | Isosorbide mononitrate 20 mg/1 | TabletOral | Proficient Rx LP | 63187-900 |