Isosorbide Mononitrate
- Product NDC
- 71335-1117
- 11-digit product format
- 713351117
- Labeler code
- 71335
- Product ID
- 71335-1117_d49a5b9e-3695-4ce0-a787-528165b13388
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075522
- Marketing category
- ANDA
- Marketing start
- 2017-01-05
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1117 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Legacy NDC | 20230528_4705ad87-a408-4253-8813-c0aba8006640.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1117-1 | 71335111701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-1) | 2019-03-05 | 0000-00-00 | No | No | Current |
| 71335-1117-2 | 71335111702 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-2) | 2019-03-05 | 0000-00-00 | No | No | Current |
| 71335-1117-3 | 71335111703 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-3) | 2019-03-05 | 0000-00-00 | No | No | Current |
| 71335-1117-4 | 71335111704 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-4) | 2019-03-05 | 0000-00-00 | No | No | Current |
| 71335-1117-5 | 71335111705 | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-5) | 2022-02-09 | 0000-00-00 | No | No | Current |