Prescription drug · ANDA
Isosorbide Mononitrate NDC 13668-105
Isosorbide mononitrate 60 mg/1 · Tablet, Extended release · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-105-01 | 1366801050113668010501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-01)Marketed from Jun 3, 2011 | |
| 13668-105-10 | 1366801051013668010510 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-10)Marketed from Jun 3, 2011 |
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
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- 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 13668-105_34e0adcc-8899-4abb-bba4-6be95d0ce2ddSPL ID 34e0adcc-8899-4abb-bba4-6be95d0ce2ddSPL set ID 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3cRxCUI 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
N413668010501followed by a unit qualifier and the quantityPackage 13668-0105-01. 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, USP 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.
About NDC 13668-105
- What is NDC 13668-105?
- 13668-105 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 60 mg/1 tablet, extended release, listed with the FDA by Torrent Pharmaceuticals Limited. It has 2 package NDCs, 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 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 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-794 |