Valsartan and Hydrochlorothiazide
- Product NDC
- 63629-7282
- 11-digit product format
- 636297282
- Labeler code
- 63629
- Product ID
- 63629-7282_5cc6eb0a-e2be-4260-ba6d-63149e41eeb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203145
- Marketing category
- ANDA
- Marketing start
- 2013-04-19
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 12.5; 320 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
- Valsartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 320 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 200284, 349353, 636042 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-7282-1 | 2020-10-16 | C162847 | 48780-1 | 9d75b9d0-6f79-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS, safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 63629-7282-2 | 2020-10-16 | C162847 | 48780-1 | 9d75b9d0-6f79-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS, safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 63629-7282-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6f79-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS, safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998 |
| 63629-7282-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6f79-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS, safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-7282-1 | Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1015 |
| 63629-7282-2 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1015 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7282 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1015 | Current NDC, Legacy NDC, 2 package rows | 20231212_167f49f0-2d39-49a2-9f9e-1359a7c7ba3d.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 |
|---|
| 63629-7282-1 | 63629728201 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-7282-1) | 2017-05-16 | 0000-00-00 | No | No | Current |
| 63629-7282-2 | 63629728202 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-7282-2) | 2017-05-16 | 0000-00-00 | No | No | Current |