Irbesartan and Hydrochlorothiazide
- Product NDC
- 46708-443
- 11-digit product format
- 467080443
- Labeler code
- 46708
- Product ID
- 46708-443_bbfa2906-f126-40a2-a5c4-8cbe19388fcc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA091370
- Marketing category
- ANDA
- Marketing start
- 2016-05-23
- Substance
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Active strength
- 12.5; 300 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| IRBESARTAN | 300 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 |
|---|
| 46708-443-10 | Irbesartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 46708-443-30 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 46708-443-90 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
| 46708-443-91 | Irbesartan and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-443 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230131_9492a1cd-c012-4b43-931d-235220065e1e.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 |
|---|
| 46708-443-10 | 46708044310 | 10 TABLET in 1 BLISTER PACK (46708-443-10) | 10 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 46708-443-30 | 46708044330 | 30 TABLET in 1 BOTTLE (46708-443-30) | 30 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 46708-443-90 | 46708044390 | 90 TABLET in 1 BOTTLE (46708-443-90) | 90 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 46708-443-91 | 46708044391 | 1000 TABLET in 1 BOTTLE (46708-443-91) | 1000 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |