Irbesartan
- Product NDC
- 65162-284
- 11-digit product format
- 651620284
- Labeler code
- 65162
- Product ID
- 65162-284_5d575575-9dee-4d65-962c-ca26b26ff85b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204740
- Marketing category
- ANDA
- Marketing start
- 2018-04-17
- Substance
- IRBESARTAN
- Active strength
- 75 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200094, 200095, 200096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-284-03 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 16 |
| 65162-284-09 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 16 |
| 65162-284-50 | Irbesartan | 500 in 1 BOTTLE | TABLET | 500 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-284 | IRBESARTAN TABLET [AMNEAL PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20241030_8c9bb449-6341-4f24-9d38-6ca952e07122.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 |
|---|
| 65162-284-03 | 65162028403 | 30 TABLET in 1 BOTTLE (65162-284-03) | 30 tablet | 2018-04-17 | 0000-00-00 | No | No | Current |
| 65162-284-09 | 65162028409 | 90 TABLET in 1 BOTTLE (65162-284-09) | 90 tablet | 2018-04-17 | 0000-00-00 | No | No | Current |
| 65162-284-50 | 65162028450 | 500 TABLET in 1 BOTTLE (65162-284-50) | 500 tablet | 2018-04-17 | 0000-00-00 | No | No | Current |