Prescription drug · ANDA
Valsartan NDC 71335-2152
Valsartan 80 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2152-1 | 7133521520171335215201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2152-1)Marketed from Aug 22, 2022 | |
| 71335-2152-2 | 7133521520271335215202 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2152-2)Marketed from Aug 22, 2022 | |
| 71335-2152-3 | 7133521520371335215203 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2152-3)Marketed from Aug 22, 2022 | |
| 71335-2152-4 | 7133521520471335215204 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2152-4)Marketed from Aug 22, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- valsartan
- Active ingredients
- Valsartan — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203311
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2152_d13819ae-123b-4891-8f6d-da45d6651906SPL ID d13819ae-123b-4891-8f6d-da45d6651906SPL set ID 7b523502-62b3-425e-960b-f0a58919d3ecRxCUI 349199UNII 80M03YXJ7I
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
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
N471335215201followed by a unit qualifier and the quantityPackage 71335-2152-01. 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 tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) • Heart failure (NYHA class II to IV), to reduce hospitalization for heart failure in adults ( 1.2 ) • Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertensio…
Excerpt only. Read the full label for complete information.
About NDC 71335-2152
- What is NDC 71335-2152?
- 71335-2152 is the product NDC for Valsartan, Valsartan 80 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valsartan.
- What is the active ingredient?
- Valsartan.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 130 other product NDCs are listed under this name. See all Valsartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valsartan 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 | Valsartan 320 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-393 | 59746-0393-3059746-0393-3259746-0393-67+1 more |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-989 | 42385-0989-0542385-0989-3042385-0989-68 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-990 | 42385-0990-0542385-0990-3042385-0990-68+1 more |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-991 | 42385-0991-0542385-0991-3042385-0991-68+1 more |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-992 | 42385-0992-0542385-0992-3042385-0992-68+1 more |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1596 | 67046-1596-03 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1574 | 67046-1574-03 |
| Valsartanvalsartan oral | Valsartan 4 mg/mL | SolutionOral | Advagen Pharma Ltd | 72888-184 | 72888-0184-1372888-0184-48 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1882 | 70771-1882-03 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1883 | 70771-1883-09 |
Other NDCs under ANDA 203311
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 | Valsartan 160 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-154 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1574 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-746 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-010 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-745 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-747 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-748 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2151 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2155 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2154 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1596 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-749 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-746 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-747 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-748 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6346 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6347 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6348 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-834 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-154 |
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