Valsartan and Hydrochlorothiazide
- Product NDC
- 50090-5345
- 11-digit product format
- 500905345
- Labeler code
- 50090
- Product ID
- 50090-5345_48d61518-d6f5-4b1e-8d5f-88cdd766a17d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA203145
- Marketing category
- ANDA
- Marketing start
- 2013-04-19
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 25; 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 | 25 mg/1 |
| VALSARTAN | 320 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 636045 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5345-0 | Valsartan 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 |
|---|
| 50090-5345 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230208_ef100fa1-dd63-4287-8543-480a82ace168.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 |
|---|
| 50090-5345-0 | 50090534500 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5345-0) | 2020-11-05 | 0000-00-00 | No | No | Current |