Irbesartan and Hydrochlorothiazide
- Product NDC
- 62332-051
- 11-digit product format
- 623320051
- Labeler code
- 62332
- Product ID
- 62332-051_08cf62b6-c618-4e6a-877a-4e26ca6e91ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA091370
- Marketing category
- ANDA
- Marketing start
- 2016-05-23
- Substance
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Active strength
- 12.5; 150 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N, 0J48LPH2TH |
| Rxcui | 310792, 310793, 485471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-051-10 | Irbesartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 18 |
| 62332-051-30 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 18 |
| 62332-051-90 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 18 |
| 62332-051-91 | Irbesartan and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-051 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20230906_e842fa14-b18e-4463-9bf1-a1c8700fe33c.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 |
|---|
| 62332-051-10 | 62332005110 | 10 TABLET in 1 BLISTER PACK (62332-051-10) | 10 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 62332-051-30 | 62332005130 | 30 TABLET in 1 BOTTLE (62332-051-30) | 30 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 62332-051-90 | 62332005190 | 90 TABLET in 1 BOTTLE (62332-051-90) | 90 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 62332-051-91 | 62332005191 | 1000 TABLET in 1 BOTTLE (62332-051-91) | 1000 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |