Prescription drug · ANDA
Valsartan NDC 65162-838
Valsartan 80 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-838-09 | 6516208380965162083809 | 90 TABLET in 1 BOTTLE (65162-838-09)Marketed from Jan 27, 2016 | |
| 65162-838-11 | 6516208381165162083811 | 1000 TABLET in 1 BOTTLE (65162-838-11)Marketed from Jan 27, 2016 | |
| 65162-838-50 | 6516208385065162083850 | 500 TABLET in 1 BOTTLE (65162-838-50)Marketed from Jan 27, 2016 |
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
- Generic name (nonproprietary)
- valsartan
- Active ingredients
- Valsartan — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204011
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-838_1959b6d0-7fd0-41c8-9455-495bc777d85eSPL ID 1959b6d0-7fd0-41c8-9455-495bc777d85e
- 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
N465162083809followed by a unit qualifier and the quantityPackage 65162-0838-09. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 65162-838
- What is NDC 65162-838?
- 65162-838 is the product NDC for Valsartan, Valsartan 80 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 204011
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 40 mg/1 | TabletOral | AvKARE | 42291-856 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | AvKARE | 42291-857 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | AvKARE | 42291-858 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | AvKARE | 42291-859 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-029 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-033 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-837 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-838 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-839 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-840 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-837 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-839 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-840 |