Isosorbide Dinitrate
- Product NDC
- 49884-020
- 11-digit product format
- 498840020
- Labeler code
- 49884
- Product ID
- 49884-020_bb122d4c-8b22-44dd-9c60-772123f18a4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA086923
- Marketing category
- ANDA
- Marketing start
- 1979-12-13
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 5 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 Dinitrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE DINITRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 197839, 206842, 314055, 381056 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-020-01 | Isosorbide Dinitrate | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 49884-020-10 | Isosorbide Dinitrate | 1000 in 1 BOTTLE | TABLET | 1000 | | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-020 | ISOSORBIDE DINITRATE TABLET [ENDO USA, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240926_6df6a2fa-c56c-4eb6-a485-c16585420eb0.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 |
|---|
| 49884-020-01 | 49884002001 | 100 TABLET in 1 BOTTLE (49884-020-01) | 100 tablet | 1979-12-13 | 0000-00-00 | No | No | Current |
| 49884-020-10 | 49884002010 | 1000 TABLET in 1 BOTTLE (49884-020-10) | 1000 tablet | 1979-12-13 | 0000-00-00 | No | No | Current |