isosorbide mononitrate
- Product NDC
- 70518-2201
- 11-digit product format
- 705182201
- Labeler code
- 70518
- Product ID
- 70518-2201_c7019427-70a3-7023-e053-2995a90a748f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075155
- Marketing category
- ANDA
- Marketing start
- 2019-07-10
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 120 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2201-0 | 70518220100 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2201-0) | 2019-07-10 | 0000-00-00 | No | No | Current |
| 70518-2201-1 | 70518220101 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2201-1) | 2020-02-14 | 0000-00-00 | No | No | Current |