ISOSORBIDE MONONITRATE
- Product NDC
- 50090-6798
- 11-digit product format
- 500906798
- Labeler code
- 50090
- Product ID
- 50090-6798_4ce3190c-27b9-48ad-a292-57a9c32dfd04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA216557
- Marketing category
- ANDA
- Marketing start
- 2022-11-07
- 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 |
|---|
| 50090-6798-0 | ISOSORBIDE MONONITRATE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 50090-6798-1 | ISOSORBIDE MONONITRATE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
| 50090-6798-2 | 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 |
|---|
| 50090-6798 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 3 package rows | 20231110_44a0f691-b826-4580-ab2d-b5d1cc99e283.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6798-0 | 50090679800 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6798-0) | 2023-11-02 | No | No | Current |
| 50090-6798-1 | 50090679801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6798-1) | 2023-11-02 | No | No | Current |
| 50090-6798-2 | 50090679802 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6798-2) | 2023-11-02 | No | No | Current |