ISOSORBIDE MONONITRATE
- Product NDC
- 50090-6661
- 11-digit product format
- 500906661
- Labeler code
- 50090
- Product ID
- 50090-6661_59d7eefa-412f-492c-994f-4f943cc87472
- 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
- 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 |
|---|
| 50090-6661-0 | ISOSORBIDE MONONITRATE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 50090-6661-1 | ISOSORBIDE MONONITRATE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
| 50090-6661-2 | 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 |
|---|
| 50090-6661 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 3 package rows | 20230906_5a8164a3-56e2-4b9b-8718-0423b4b4958f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6661-0 | 50090666100 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6661-0) | 2023-08-30 | No | No | Historical |
| 50090-6661-1 | 50090666101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6661-1) | 2023-08-30 | No | No | Historical |
| 50090-6661-2 | 50090666102 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6661-2) | 2023-08-30 | No | No | Historical |