Isosorbide Mononitrate
- Product NDC
- 67046-1632
- 11-digit product format
- 670461632
- Labeler code
- 67046
- Product ID
- 67046-1632_46b2f5a6-295b-3549-e063-6394a90a514d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA075522
- Marketing category
- ANDA
- Marketing start
- 2025-12-24
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Mononitrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1632-3 | Isosorbide Mononitrate | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1632-3 | 67046163203 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1632-3) | 2025-12-24 | No | No | Historical |