Irbesartan
- Product NDC
- 31722-729
- 11-digit product format
- 317220729
- Labeler code
- 31722
- Product ID
- 31722-729_4cd3482f-1ad1-1839-e063-6394a90a44d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2027-12-31
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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IRBESARTAN | ACTIVE INGREDIENT | J0E2756Z7N | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| IRBESARTAN | ACTIVE MOIETY | J0E2756Z7N | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| CARBOXYMETHYLCELLULOSE CALCIUM | INACTIVE INGREDIENT | UTY7PDF93L | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | IRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| IRBESARTAN | ACTIVE INGREDIENT | J0E2756Z7N | IRBESARTAN TABLET [AVPAK] | 1 | |
| IRBESARTAN | ACTIVE MOIETY | J0E2756Z7N | IRBESARTAN TABLET [AVPAK] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | IRBESARTAN TABLET [AVPAK] | 1 | |
| CARBOXYMETHYLCELLULOSE CALCIUM | INACTIVE INGREDIENT | UTY7PDF93L | IRBESARTAN TABLET [AVPAK] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IRBESARTAN TABLET [AVPAK] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IRBESARTAN TABLET [AVPAK] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | IRBESARTAN TABLET [AVPAK] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-729 | IRBESARTAN (IRBESARTAN) TABLET [CAMBER PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 6 package rows | 20231026_33416f1e-adee-4a45-b6fe-1fc39044e307.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 |
|---|
| 31722-729-05 | 31722072905 | 500 TABLET in 1 BOTTLE (31722-729-05) | 500 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |
| 31722-729-10 | 31722072910 | 1000 TABLET in 1 BOTTLE (31722-729-10) | 1000 tablet | 2025-03-06 | | No | No | Current |
| 31722-729-30 | 31722072930 | 30 TABLET in 1 BOTTLE (31722-729-30) | 30 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |
| 31722-729-31 | 31722072931 | 120 BLISTER PACK in 1 CARTON (31722-729-31) / 10 TABLET in 1 BLISTER PACK | 120 blister pack | 2012-09-27 | 0000-00-00 | No | No | Current |
| 31722-729-90 | 31722072990 | 90 TABLET in 1 BOTTLE (31722-729-90) | 90 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |