Amlodipine and valsartan NDC 65862-740

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-740Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0740Add 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
65862-740-03	65862074003	3 BLISTER PACK in 1 CARTON (65862-740-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-740-10)Marketed from Apr 22, 2016
65862-740-30	65862074030	30 TABLET, FILM COATED in 1 BOTTLE (65862-740-30)Marketed from Apr 22, 2016
65862-740-90	65862074090	90 TABLET, FILM COATED in 1 BOTTLE (65862-740-90)Marketed from Apr 22, 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): 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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206512
Marketing start: Apr 22, 2016
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 65862-740_909d72a6-7116-407e-8ec8-77b9b5798237SPL ID 909d72a6-7116-407e-8ec8-77b9b5798237SPL set ID 7fa25f10-29e0-4162-81a8-9d2e03054dedRxCUI 722126, 722131, 722134, 722137UNII 864V2Q084H, 80M03YXJ7IUPC 0365862739308, 0365862737304
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

N465862074003 followed by a unit qualifier and the quantity

Package 65862-0740-03. 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 May 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine and valsartan tablets are the combination 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 blood press…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206512

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

FDA NDC Directory listings under ANDA 206512
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine and valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-737
Amlodipine and valsartan	Amlodipine besylate 5 mg/1; Valsartan 320 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-738
Amlodipine and valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-739