Irbesartan and Hydrochlorothiazide
- Product NDC
- 63187-653
- 11-digit product format
- 631870653
- Labeler code
- 63187
- Product ID
- 63187-653_2c82bb30-406c-4b3e-9834-ed32ea065bf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202414
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- 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
- 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 | 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 |
|---|
| 63187-653-30 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 63187-653-60 | Irbesartan and Hydrochlorothiazide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 63187-653-90 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-653 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20210113_97b09783-7bba-4f7a-b1b3-86ccf12c7ecc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-653-30 | 63187065330 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-653-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-653-60 | 63187065360 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-653-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-653-90 | 63187065390 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-653-90) | 2018-12-01 | 0000-00-00 | No | No | Current |