VALSARTAN AND HYDROCHLOROTHIAZIDE
- Product NDC
- 43547-312
- 11-digit product format
- 435470312
- Labeler code
- 43547
- Product ID
- 43547-312_2d03a607-2ffd-4df1-8c94-bec2b786709c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA206083
- Marketing category
- ANDA
- Marketing start
- 2015-10-31
- 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 | 80M03YXJ7I, 0J48LPH2TH |
| Rxcui | 200284, 200285, 349353, 636042, 636045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-312-03 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 43547-312-09 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 23 |
| 43547-312-50 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-312 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 22 | Current NDC, Legacy NDC, 3 package rows | 20230619_f8b0a8ab-4549-4553-a127-bf2c0291a4b1.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 |
|---|
| 43547-312-03 | 43547031203 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-312-03) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 43547-312-09 | 43547031209 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-312-09) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 43547-312-50 | 43547031250 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-312-50) | 2021-12-03 | 0000-00-00 | No | No | Current |