Valsartan and Hydrochlorothiazide
- Product NDC
- 51655-389
- 11-digit product format
- 516550389
- Labeler code
- 51655
- Product ID
- 51655-389_48fedb0d-d803-7788-e063-6294a90a03e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078020
- Marketing category
- ANDA
- Marketing start
- 2023-03-29
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 12.5; 160 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
- Valsartan and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 200285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-389-52 | Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-389 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20240723_f835fa93-6529-c06d-e053-6394a90ad42a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-389-52 | 51655038952 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-389-52) | 2023-03-29 | No | No | Historical |