Irbesartan
- Product NDC
- 71205-452
- 11-digit product format
- 712050452
- Labeler code
- 71205
- Product ID
- 71205-452_208cd661-160f-46e4-b9d1-6eaf7bd39ba0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- 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 |
|---|
| 71205-452-30 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71205-452-60 | Irbesartan | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 71205-452-90 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-452 | IRBESARTAN TABLET [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220512_950e33da-5e77-40df-b73b-dd084b36a804.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 |
|---|
| 71205-452-30 | 71205045230 | 30 TABLET in 1 BOTTLE (71205-452-30) | 30 tablet | 2020-04-01 | 0000-00-00 | No | No | Current |
| 71205-452-60 | 71205045260 | 60 TABLET in 1 BOTTLE (71205-452-60) | 60 tablet | 2020-04-01 | 0000-00-00 | No | No | Current |
| 71205-452-90 | 71205045290 | 90 TABLET in 1 BOTTLE (71205-452-90) | 90 tablet | 2020-04-01 | 0000-00-00 | No | No | Current |