Irbesartan and Hydrochlorothiazide
- Product NDC
- 71335-1097
- 11-digit product format
- 713351097
- Labeler code
- 71335
- Product ID
- 71335-1097_04ca597a-0797-4dd7-b85e-9d9bdcad68c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077369
- Marketing category
- ANDA
- Marketing start
- 2013-01-24
- 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1097-1 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 71335-1097-2 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 71335-1097-3 | Irbesartan and Hydrochlorothiazide | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1097 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 4 | Current NDC, Legacy NDC, 3 package rows | 20231116_5eabb13d-f6fd-4091-9909-c4f0c5922289.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 |
|---|
| 71335-1097-1 | 71335109701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1097-1) | 2019-02-12 | 0000-00-00 | No | No | Current |
| 71335-1097-2 | 71335109702 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1097-2) | 2021-03-17 | 0000-00-00 | No | No | Current |
| 71335-1097-3 | 71335109703 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1097-3) | 2022-04-08 | 0000-00-00 | No | No | Current |