Prescription drug · ANDA
Isosorbide Mononitrate NDC 60687-794
Isosorbide mononitrate 60 mg/1 · Tablet, Extended release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-794-01 | 6068707940160687079401 | 100 BLISTER PACK in 1 CARTON (60687-794-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-794-11)Marketed from Oct 23, 2023 |
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 — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 60687
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200495
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 60687-794_5c3f0de0-9544-2a94-e063-6394a90abe35SPL ID 5c3f0de0-9544-2a94-e063-6394a90abe35
- 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
N460687079401followed by a unit qualifier and the quantityPackage 60687-0794-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60687-794
- What is NDC 60687-794?
- 60687-794 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 60 mg/1 tablet, extended release, listed with the FDA by American Health Packaging. 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?
- American Health Packaging, NDC labeler code 60687. 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 ANDA 200495
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 60 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7768 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-6450 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-105 |
| Isosorbide Mononitrate | Isosorbide mononitrate 120 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-106 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-7292 |