What is NDC 43386-080?

43386-080 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Amlodipine besylate, Valsartan.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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?

39 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 43386-080

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0080Add 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
43386-080-03	4338600800343386008003	30 TABLET in 1 BOTTLE (43386-080-03)Marketed from Mar 30, 2015
43386-080-09	4338600800943386008009	90 TABLET in 1 BOTTLE (43386-080-09)Marketed from Mar 30, 2015

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
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202829
Marketing start: Mar 30, 2015
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 43386-080_8d66a9ba-050e-4993-939b-f2c858760a0cSPL ID 8d66a9ba-050e-4993-939b-f2c858760a0cSPL set ID e05dd72c-7475-422e-bf8e-73148929450eRxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 864V2Q084HUPC 0343386083039, 0343386082094, 0343386080090, 0343386081035
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

N443386008003 followed by a unit qualifier and the quantity

Package 43386-0080-03. 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 Jun 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine and Valsartan Tablet are the combination tablets of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on 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. 1.1 Hypertension Amlodipine and Valsartan Tablets are indicated for the treatment of hypertension, to lower blo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-080

What is NDC 43386-080?: 43386-080 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. 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?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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?: 39 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 320 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-023	71209-0023-0171209-0023-04
Amlodipine And Valsartan	Amlodipine besylate 10 mg/1; Valsartan 320 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-024	71209-0024-0171209-0024-04
Amlodipine And Valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-022	71209-0022-0171209-0022-04
Amlodipine And Valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-021	71209-0021-0171209-0021-04
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 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 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

All 40 Amlodipine And Valsartan NDCs

Other NDCs under ANDA 202829

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

FDA NDC Directory listings under ANDA 202829
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine And Valsartan	Amlodipine besylate 5 mg/1; Valsartan 320 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-081
Amlodipine And Valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-082
Amlodipine And Valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-083