Irbesartan
- Product NDC
- 71335-2168
- 11-digit product format
- 713352168
- Labeler code
- 71335
- Product ID
- 71335-2168_f8e0d3a4-3293-4db6-861a-238dd17c9d45
- 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
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200095 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2168-1 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 101 |
| 71335-2168-2 | Irbesartan | 60 in 1 BOTTLE | TABLET | 60 | | 101 |
| 71335-2168-3 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2168 | IRBESARTAN TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 3 package rows | 20231128_1ab1ff46-d0b1-4762-9ebf-3e07dde8b048.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 |
|---|
| 71335-2168-1 | 71335216801 | 30 TABLET in 1 BOTTLE (71335-2168-1) | 30 tablet | 2022-09-06 | 0000-00-00 | No | No | Current |
| 71335-2168-2 | 71335216802 | 60 TABLET in 1 BOTTLE (71335-2168-2) | 60 tablet | 2022-09-06 | 0000-00-00 | No | No | Current |
| 71335-2168-3 | 71335216803 | 90 TABLET in 1 BOTTLE (71335-2168-3) | 90 tablet | 2022-09-06 | 0000-00-00 | No | No | Current |