ISOSORBIDE MONONITRATE
- Product NDC
- 68382-651
- 11-digit product format
- 683820651
- Labeler code
- 68382
- Product ID
- 68382-651_0f30ef5c-bdf6-4823-8483-8d40cfe4e460
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA075395
- Marketing category
- ANDA
- Marketing start
- 2013-12-19
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-651-01 | ISOSORBIDE MONONITRATE | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 68382-651-05 | ISOSORBIDE MONONITRATE | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-651 | ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ] | 7 | Legacy NDC, 2 package rows | 20211218_897a0327-25d4-4769-bd6a-0e674264017f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-651-01 | 68382065101 | 100 TABLET in 1 BOTTLE (68382-651-01) | 100 tablet | 2013-12-19 | 0000-00-00 | No | No | Current |
| 68382-651-05 | 68382065105 | 500 TABLET in 1 BOTTLE (68382-651-05) | 500 tablet | 2013-12-19 | 0000-00-00 | No | No | Current |