Irbesartan
- Product NDC
- 83008-084
- 11-digit product format
- 830080084
- Labeler code
- 83008
- Product ID
- 83008-084_e5af9766-e94f-4240-b3ff-2565a89ba702
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2024-08-28
- Marketing end
- 2027-05-31
- Substance
- IRBESARTAN
- Active strength
- 150 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200094, 200095 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83008-084-30 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83008-084 | IRBESARTAN (IRBESARTAN) TABLET [QUALITY CARE PRODUCTS, LLC] | 4 | Current NDC, 1 package rows | 20241222_9b8581c1-d052-4fe2-a9fc-cf7adf0f9061.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 |
|---|
| 83008-084-30 | 83008008430 | 30 TABLET in 1 BOTTLE (83008-084-30) | 30 tablet | 2024-08-28 | 2027-05-31 | No | No | Historical |