Irbesartan
- Product NDC
- 50228-160
- 11-digit product format
- 502280160
- Labeler code
- 50228
- Product ID
- 50228-160_ba124fb5-fa8b-be15-e053-2a95a90ab560
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA204774
- Marketing category
- ANDA
- Marketing start
- 2015-12-07
- 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 |
|---|
| 50228-160-05 | Irbesartan | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 50228-160-30 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-160 | IRBESARTAN (IRBESARTAN) TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210131_ddca7d7c-07fe-4df6-83ae-a9c05048b66e.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 |
|---|
| 50228-160-05 | 50228016005 | 500 TABLET in 1 BOTTLE (50228-160-05) | 500 tablet | 2015-12-07 | 0000-00-00 | No | No | Current |
| 50228-160-30 | 50228016030 | 30 TABLET in 1 BOTTLE (50228-160-30) | 30 tablet | 2015-12-07 | 0000-00-00 | No | No | Current |