ISOSORBIDE MONONITRATE
- Product NDC
- 0615-8044
- 11-digit product format
- 006158044
- Labeler code
- 0615
- Product ID
- 0615-8044_32d9d4bb-e603-411e-a2e7-995a46c0bf40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA075395
- Marketing category
- ANDA
- Marketing start
- 2013-12-19
- Marketing end
- 2023-11-30
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0615-8044-05 | 00615804405 | 15 TABLET in 1 BLISTER PACK (0615-8044-05) | 15 tablet | 2016-05-09 | 2023-11-30 | No | No | Current |
| 0615-8044-39 | 00615804439 | 30 TABLET in 1 BLISTER PACK (0615-8044-39) | 30 tablet | 2016-05-09 | 2023-11-30 | No | No | Current |