Prescription drug · NDA AUTHORIZED GENERIC
isosorbide mononitrate NDC 62175-107
Isosorbide mononitrate 20 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62175-107-01 | 62175010701 | 100 TABLET in 1 BOTTLE (62175-107-01)Marketed from Jun 30, 1993 |
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
- Lannett Company, Inc.
- 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 62175-107_81e3e7e0-b677-4948-9e04-6c3a44ea313bSPL ID 81e3e7e0-b677-4948-9e04-6c3a44ea313bSPL set ID bf9e7e35-7707-42a0-88d6-6292fa52bbfaRxCUI 311192, 311197UNII LX1OH63030UPC 0362175107015, 0362175106018
- 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
N462175010701followed by a unit qualifier and the quantityPackage 62175-0107-01. 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 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 10 mg/1 | TabletOral | Coupler LLC | 67046-1577 |
| 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 |