Irbesartan and Hydrochlorothiazide
- Product NDC
- 71335-1787
- 11-digit product format
- 713351787
- Labeler code
- 71335
- Product ID
- 71335-1787_1c842673-6489-419f-a5f3-7a3454a43efb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090351
- Marketing category
- ANDA
- Marketing start
- 2012-10-15
- 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 | 0J48LPH2TH, J0E2756Z7N |
| Rxcui | 310792 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1787-1 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 104 |
| 71335-1787-2 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 104 |
| 71335-1787-3 | Irbesartan and Hydrochlorothiazide | 28 in 1 BOTTLE | TABLET | 28 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1787 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 3 package rows | 20240524_e6c35575-9c3f-42f8-b8b8-577a29f9d381.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 |
|---|
| 71335-1787-1 | 71335178701 | 30 TABLET in 1 BOTTLE (71335-1787-1) | 30 tablet | 2021-08-12 | 0000-00-00 | No | No | Current |
| 71335-1787-2 | 71335178702 | 90 TABLET in 1 BOTTLE (71335-1787-2) | 90 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1787-3 | 71335178703 | 28 TABLET in 1 BOTTLE (71335-1787-3) | 28 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |