Irbesartan
- Product NDC
- 31722-160
- 11-digit product format
- 317220160
- Labeler code
- 31722
- Product ID
- 31722-160_0f3408b4-44be-4a92-a59f-9b5a9716bc9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204774
- Marketing category
- ANDA
- Marketing start
- 2016-10-06
- 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 |
|---|
| 31722-160-05 | Irbesartan | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-160 | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20161007_0f3408b4-44be-4a92-a59f-9b5a9716bc9a.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 |
|---|
| 31722-160-05 | 31722016005 | 500 TABLET in 1 BOTTLE (31722-160-05) | 500 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |