Prescription drug · ANDA
Valsartan and Hydrochlorothiazide NDC 71205-258
Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-258-30 | 7120502583071205025830 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-258-30)Marketed from May 1, 2019 | |
| 71205-258-60 | 7120502586071205025860 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-258-60)Marketed from May 1, 2019 | |
| 71205-258-90 | 7120502589071205025890 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-258-90)Marketed from May 1, 2019 |
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
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203145
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71205-258_09764c50-8d91-4c74-8d5f-d48f79ecb01cSPL ID 09764c50-8d91-4c74-8d5f-d48f79ecb01cSPL set ID a9098fc6-3d2a-404f-a4cd-2e181ebbd626RxCUI 200285UNII 80M03YXJ7I, 0J48LPH2THUPC 0371205258306
- 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
N471205025830followed by a unit qualifier and the quantityPackage 71205-0258-30. 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, USP 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 ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, l…
Excerpt only. Read the full label for complete information.
About NDC 71205-258
- What is NDC 71205-258?
- 71205-258 is the product NDC for Valsartan and Hydrochlorothiazide, Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valsartan and Hydrochlorothiazide.
- What is the active ingredient?
- Valsartan, Hydrochlorothiazide.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valsartan and Hydrochlorothiazide?
- 98 other product NDCs are listed under this name. See all Valsartan and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valsartan and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-148 | 50228-0148-1050228-0148-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-147 | 50228-0147-1050228-0147-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-151 | 50228-0151-0550228-0151-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-149 | 50228-0149-1050228-0149-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-150 | 50228-0150-0550228-0150-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-073 | 84677-0073-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-072 | 84677-0072-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-076 | 84677-0076-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-074 | 84677-0074-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-075 | 84677-0075-90 |
Other NDCs under ANDA 203145
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 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-074 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-075 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-076 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-077 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-078 |
| Valsartan and Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3576 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5345 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5570 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6210 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-655 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-698 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7282 |
| Valsartan and Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-327 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0547 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-054 |