Prescription drug · ANDA
Valsartan And Hydrochlorothiazide NDC 50228-148
Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-148-10 | 50228014810 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-148-10)Marketed from Jul 27, 2026 | |
| 50228-148-30 | 50228014830 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-148-30)Marketed from Jul 27, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Valsartan And Hydrochlorothiazide
- Generic name (nonproprietary)
- valsartan and hydrochlorothiazide
- Active ingredients
- Valsartan — 160 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204687
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 50228-148_1d11c062-0075-4a21-bf41-61545d591adcSPL ID 1d11c062-0075-4a21-bf41-61545d591adcSPL set ID 17362ff8-07bb-42c6-a100-8adb93be0348RxCUI 200284, 200285, 349353, 636042, 636045UNII 80M03YXJ7I, 0J48LPH2THUPC 0350228148306, 0350228147309, 0350228149303, 0350228150309, 0350228151306
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450228014810followed by a unit qualifier and the quantityPackage 50228-0148-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, incl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204687
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-150 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-151 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-149 |
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-147 |
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-072 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-074 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-073 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-075 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-076 |