What is NDC 71209-021?

71209-021 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 5 mg/1; Valsartan 160 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 is the active ingredient?

Amlodipine besylate, Valsartan.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amlodipine And Valsartan NDC 71209-021

NDC codes

FDA NDC Directory

Product NDC (as listed)71209-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71209-0021Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71209-021-01	7120900210171209002101	30 TABLET, FILM COATED in 1 BOTTLE (71209-021-01)Marketed from Oct 22, 2026
71209-021-04	7120900210471209002104	90 TABLET, FILM COATED in 1 BOTTLE (71209-021-04)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 — 5 mg/1Valsartan — 160 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: Oct 22, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 71209-021_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

N471209002101 followed by a unit qualifier and the quantity

Package 71209-0021-01. 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 71209-021

What is NDC 71209-021?: 71209-021 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 5 mg/1; Valsartan 160 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amlodipine And Valsartan NDCs
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

All 36 Amlodipine And Valsartan NDCs

Other NDCs under ANDA 205797

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205797
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 320 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-024
Amlodipine And Valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-022