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	43386008003	30 TABLET in 1 BOTTLE (43386-080-03)Marketed from Mar 30, 2015
43386-080-09	43386008009	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202829
Marketing start: Mar 30, 2015
Listing expires: Dec 31, 2026
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 864V2Q084H, 80M03YXJ7IUPC 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)

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