ISOSORBIDE MONONITRATE
- Product NDC
- 67046-1446
- 11-digit product format
- 670461446
- Labeler code
- 67046
- Product ID
- 67046-1446_2d9988ef-55cb-3043-e063-6294a90a1851
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA216557
- Marketing category
- ANDA
- Marketing start
- 2025-02-07
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 317110 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1446-3 | ISOSORBIDE MONONITRATE | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1446 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250212_2d99893a-296a-134c-e063-6294a90ace3b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1446-3 | 67046144603 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1446-3) | 2025-02-07 | No | No | Current |