Isosorbide Mononitrate
- Product NDC
- 51655-922
- 11-digit product format
- 516550922
- Labeler code
- 51655
- Product ID
- 51655-922_497428e5-d404-55ce-e063-6394a90ab8ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA210918
- Marketing category
- ANDA
- Marketing start
- 2022-03-18
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Mononitrate
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-922-52 | Isosorbide Mononitrate | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-922 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231219_df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3.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 |
|---|
| 51655-922-52 | 51655092252 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-922-52) | 2022-03-18 | 0000-00-00 | No | No | Current |