ISOSORBIDE DINITRATE
- Product NDC
- 0615-8464
- 11-digit product format
- 006158464
- Labeler code
- 0615
- Product ID
- 0615-8464_e52655b8-2c52-4534-9f86-bb70ebff3321
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA215723
- Marketing category
- ANDA
- Marketing start
- 2022-07-08
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 197839, 206842, 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8464-39 | ISOSORBIDE DINITRATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8464 | ISOSORBIDE DINITRATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20230524_74a7f767-fa2f-4640-be24-34a8a9128217.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8464-39 | 00615846439 | 30 TABLET in 1 BLISTER PACK (0615-8464-39) | 30 tablet | 2023-05-15 | No | No | Current |