isosorbide mononitrate
- Product NDC
- 50268-452
- 11-digit product format
- 502680452
- Labeler code
- 50268
- Product ID
- 50268-452_d5ddc220-c177-6420-e053-2a95a90a5916
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA075155
- Marketing category
- ANDA
- Marketing start
- 2012-12-13
- 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
- 2023-12-31
- 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 |
|---|
| 50268-452-15 | 50268045215 | 50 BLISTER PACK in 1 BOX (50268-452-15) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-452-11) | 50 blister pack | 2012-12-13 | 0000-00-00 | No | No | Current |