Irbesartan and Hydrochlorothiazide
- Product NDC
- 70518-1550
- 11-digit product format
- 705181550
- Labeler code
- 70518
- Product ID
- 70518-1550_494c124c-6d02-4add-e063-6394a90a26f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203072
- Marketing category
- ANDA
- Marketing start
- 2018-10-18
- 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
- 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, J0E2756Z7N |
| Rxcui | 310793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1550-0 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 12 |
| 70518-1550-1 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1550 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [REMEDYREPACK INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250226_88aaa2a1-13be-4f56-ace6-66e899028007.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 |
|---|
| 70518-1550-0 | 70518155000 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-0) | 90 tablet | 2018-10-18 | 0000-00-00 | No | No | Current |
| 70518-1550-1 | 70518155001 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-1) | 90 tablet | 2025-08-27 | | No | No | Current |