Prescription drug · ANDA
Amlodipine And Valsartan NDC 71209-024
Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 · Tablet, Film coated · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-024-01 | 7120900240171209002401 | 30 TABLET, FILM COATED in 1 BOTTLE (71209-024-01)Marketed from Oct 22, 2026 | |
| 71209-024-04 | 7120900240471209002404 | 90 TABLET, FILM COATED in 1 BOTTLE (71209-024-04)Marketed from Oct 22, 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)
- Amlodipine And Valsartan
- Generic name (nonproprietary)
- amlodipine and valsartan
- Active ingredients
- Amlodipine besylate — 10 mg/1Valsartan — 320 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cadila Pharmaceuticals LimitedNDC labeler code 71209
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205797
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 71209-024_5ea0b9e9-1f6c-49a9-a5db-e50da5721e60SPL ID 5ea0b9e9-1f6c-49a9-a5db-e50da5721e60
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel 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
N471209002401followed by a unit qualifier and the quantityPackage 71209-0024-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 71209-024
- What is NDC 71209-024?
- 71209-024 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 tablet, film coated, listed with the FDA by Cadila Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine And Valsartan.
- What is the active ingredient?
- Amlodipine besylate, Valsartan.
- Who is the labeler?
- Cadila Pharmaceuticals Limited, NDC labeler code 71209. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amlodipine And Valsartan?
- 35 other product NDCs are listed under this name. See all Amlodipine And Valsartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine And 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) |
|---|---|---|---|---|---|
| amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-279 | 33342-0279-0733342-0279-1033342-0279-12 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-280 | 33342-0280-0733342-0280-1033342-0280-12 |
| amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-281 | 33342-0281-0733342-0281-1033342-0281-12 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-282 | 33342-0282-0733342-0282-1033342-0282-12 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-844 | 23155-0844-0323155-0844-09 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-845 | 23155-0845-0323155-0845-09 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 320 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-846 | 23155-0846-0323155-0846-09 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 320 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-847 | 23155-0847-0323155-0847-09 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-458 | 46708-0458-1046708-0458-3046708-0458-31+2 more |
| Amlodipine and Valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-459 | 46708-0459-1046708-0459-3046708-0459-31+2 more |
Other NDCs under ANDA 205797
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 |
|---|---|---|---|---|
| Amlodipine And Valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-023 |
| Amlodipine And Valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-022 |
| Amlodipine And Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-021 |