Isosorbide Dinitrate
- Product NDC
- 43353-139
- 11-digit product format
- 433530139
- Labeler code
- 43353
- Product ID
- 43353-139_2f4be110-f156-465a-861d-fe406e0fd037
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA086925
- Marketing category
- ANDA
- Marketing start
- 2015-09-04
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 43353-139 | ISOSORBIDE DINITRATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20160707_7effb3dd-d0e6-4212-8e21-87e259330f6c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-139-60 | 43353013960 | 90 TABLET in 1 BOTTLE (43353-139-60) | 90 tablet | 2016-02-19 | 0000-00-00 | No | No | Current |