Isosorbide Mononitrate
- Product NDC
- 0228-2631
- 11-digit product format
- 002282631
- Labeler code
- 0228
- Product ID
- 0228-2631_1cb05f66-1c19-4300-8745-8c74c1dccb2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075037
- Marketing category
- ANDA
- Marketing start
- 1998-10-30
- Marketing end
- 2027-02-28
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Mononitrate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 311192, 311197 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-2631-11 | Isosorbide Mononitrate | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISOSORBIDE MONONITRATE | ACTIVE INGREDIENT | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| ISOSORBIDE MONONITRATE | ACTIVE MOIETY | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-2631 | ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20241208_ae8f74f0-e600-4452-8557-958b603e2709.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0228-2631-11 | 00228263111 | 100 TABLET in 1 BOTTLE (0228-2631-11) | 100 tablet | 1998-10-30 | 2027-02-28 | No | No | Current |