Prescription drug · ANDA
Valsartan and Hydrochlorothiazide NDC 71205-249
Hydrochlorothiazide 12.5 mg/1; Valsartan 80 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-249-30 | 7120502493071205024930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-249-30)Marketed from Apr 1, 2019 | |
| 71205-249-60 | 7120502496071205024960 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-249-60)Marketed from Apr 1, 2019 | |
| 71205-249-90 | 7120502499071205024990 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-249-90)Marketed from Apr 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
- Hydrochlorothiazide — 12.5 mg/1Valsartan — 80 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 078946
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71205-249_3129e59a-5814-4050-bd80-29f469ca66a2SPL ID 3129e59a-5814-4050-bd80-29f469ca66a2SPL set ID be008c6a-6036-4abf-a3fc-450465c88d55RxCUI 200284UNII 0J48LPH2TH, 80M03YXJ7I
- 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
N471205024930followed by a unit qualifier and the quantityPackage 71205-0249-30. 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 tablet USP is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled with monotherapy ( 1 ) • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pr…
Excerpt only. Read the full label for complete information.
About NDC 71205-249
- What is NDC 71205-249?
- 71205-249 is the product NDC for Valsartan and Hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1; Valsartan 80 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?
- Hydrochlorothiazide, Valsartan.
- 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 078946
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 | Hydrochlorothiazide 12.5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-101 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-102 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Valsartan 80 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-103 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-104 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-105 |