Irbesartan and Hydrochlorothiazide
- Product NDC
- 72162-2317
- 11-digit product format
- 721622317
- Labeler code
- 72162
- Product ID
- 72162-2317_f6dbcced-c0f8-4a3d-8a3a-38d616dd4889
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203072
- Marketing category
- ANDA
- Marketing start
- 2014-03-01
- 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 |
|---|
| 72162-2317-3 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 102 |
| 72162-2317-9 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2317 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, 2 package rows | 20241109_53ce6e4f-db3a-4789-8bef-1e459fa78b79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2317-3 | 72162231703 | 30 TABLET in 1 BOTTLE (72162-2317-3) | 30 tablet | 2014-03-01 | No | No | Historical |
| 72162-2317-9 | 72162231709 | 90 TABLET in 1 BOTTLE (72162-2317-9) | 90 tablet | 2014-03-01 | No | No | Historical |