Isosorbide Mononitrate
- Product NDC
- 71610-338
- 11-digit product format
- 716100338
- Labeler code
- 71610
- Product ID
- 71610-338_e6ce8fcb-476d-40f5-b38f-be1f7253353e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA210918
- Marketing category
- ANDA
- Marketing start
- 2018-11-05
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-338-30 | Isosorbide Mononitrate | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 71610-338-60 | Isosorbide Mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-338 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 2 package rows | 20190831_9ea70e22-9687-40eb-9388-744768a2b33a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-338-30 | 71610033830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-338-30) | 2019-08-15 | 0000-00-00 | No | No | Current |
| 71610-338-60 | 71610033860 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-338-60) | 2019-08-15 | 0000-00-00 | No | No | Current |