Prescription drug · ANDA
Isosorbide Mononitrate NDC 51407-210
Isosorbide mononitrate 120 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-210-01 | 51407021001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-210-01)Marketed from Apr 19, 2019 |
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 — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210918
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 51407-210_26ab803d-04f8-b766-e063-6394a90a117fSPL ID 26ab803d-04f8-b766-e063-6394a90a117fSPL set ID 86be0e85-5337-bee4-e053-2a91aa0a8158RxCUI 311196, 317110, 353538UNII 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
N451407021001followed by a unit qualifier and the quantityPackage 51407-0210-01. 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 extended-release tablets are indicated for the prevention 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 210918
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 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-922 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-175 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-176 |
| Isosorbide Mononitrate | Isosorbide mononitrate 120 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-177 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-772 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7038 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-788 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-208 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-825 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-209 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2194 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2192 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5686 |