IRBESARTAN
- Product NDC
- 62332-043
- 11-digit product format
- 623320043
- Labeler code
- 62332
- Product ID
- 62332-043_e21c14f4-6c8c-4676-b479-dff181ec3fa1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA091236
- Marketing category
- ANDA
- Marketing start
- 2016-07-01
- Substance
- IRBESARTAN
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200094, 200095, 200096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-043 | IRBESARTAN TABLET [ALEMBIC PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 5 package rows | 20211223_83f5d5c8-27c0-4208-a291-0c4aa55a1ff5.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 |
|---|
| 62332-043-30 | 62332004330 | 30 TABLET in 1 BOTTLE (62332-043-30) | 30 tablet | 2016-07-01 | 0000-00-00 | No | No | Current |
| 62332-043-31 | 62332004331 | 100 TABLET in 1 BOTTLE (62332-043-31) | 100 tablet | 2016-07-01 | 0000-00-00 | No | No | Current |
| 62332-043-71 | 62332004371 | 500 TABLET in 1 BOTTLE (62332-043-71) | 500 tablet | 2016-07-01 | 0000-00-00 | No | No | Current |
| 62332-043-90 | 62332004390 | 90 TABLET in 1 BOTTLE (62332-043-90) | 90 tablet | 2016-07-01 | 0000-00-00 | No | No | Current |
| 62332-043-91 | 62332004391 | 1000 TABLET in 1 BOTTLE (62332-043-91) | 1000 tablet | 2016-07-01 | 0000-00-00 | No | No | Current |