Amlodipine, Valsartan and Hydrochlorothiazide NDC 68180-774

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-774Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0774Add the package segment from the table below.

Product information

Brand name (proprietary): Amlodipine, Valsartan and Hydrochlorothiazide
Generic name (nonproprietary): amlodipine, valsartan and hydrochlorothiazide
Active ingredients: Amlodipine besylate — 10 mg/1Valsartan — 160 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200797
Marketing start: Jun 4, 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)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 68180-774_5e938b33-b86d-40ab-b5c5-b7137ef9404dSPL ID 5e938b33-b86d-40ab-b5c5-b7137ef9404dSPL set ID 5dbb43b1-3ea4-4fa5-a9aa-95d869ae65feRxCUI 848131, 848135, 848140, 848145, 848151UNII 864V2Q084H, 0J48LPH2TH, 80M03YXJ7I
Pharmacologic class: Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; Thiazide Diuretic

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.

Product label

Current FDA label (SPL), effective Dec 14, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200797

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

FDA NDC Directory listings under ANDA 200797
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-771
Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-772
Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-773
Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-775