ISOSORBIDE MONONITRATE
- Product NDC
- 0615-8043
- 11-digit product format
- 006158043
- Labeler code
- 0615
- Product ID
- 0615-8043_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
- 2023-10-31
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 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 table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8043-05 | 00615804305 | 15 TABLET in 1 BLISTER PACK (0615-8043-05) | 15 tablet | 2016-05-13 | 2023-10-31 | No | No | Current |
| 0615-8043-30 | 00615804330 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8043-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2016-05-19 | 2023-10-31 | No | No | Current |
| 0615-8043-39 | 00615804339 | 30 TABLET in 1 BLISTER PACK (0615-8043-39) | 30 tablet | 2016-05-13 | 2023-10-31 | No | No | Current |