Irbesartan
- Product NDC
- 71335-0071
- 11-digit product format
- 713350071
- Labeler code
- 71335
- Product ID
- 71335-0071_44563b18-6fe8-47e2-93bd-9a326eaf9382
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203071
- Marketing category
- ANDA
- Marketing start
- 2016-06-13
- 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 | 200096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-0071-1 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 71335-0071-2 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
| 71335-0071-3 | Irbesartan | 28 in 1 BOTTLE | TABLET | 28 | | 6 |
| 71335-0071-4 | Irbesartan | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0071 | IRBESARTAN TABLET [BRYANT RANCH PREPACK] | 6 | Current NDC, Legacy NDC, 4 package rows | 20231128_efcd5f2e-1837-44ae-bc91-410c4d8b27c7.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 |
|---|
| 71335-0071-1 | 71335007101 | 30 TABLET in 1 BOTTLE (71335-0071-1) | 30 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0071-2 | 71335007102 | 90 TABLET in 1 BOTTLE (71335-0071-2) | 90 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0071-3 | 71335007103 | 28 TABLET in 1 BOTTLE (71335-0071-3) | 28 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0071-4 | 71335007104 | 60 TABLET in 1 BOTTLE (71335-0071-4) | 60 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |