NDC product

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

NDC 64380-201 · Strides Pharma Science Limited

Key facts

Product NDC 64380-201
Proprietary name AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
Nonproprietary name amlodipine besylate valsartan hydrochlorothiazide
Substances AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, VALSARTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Strides Pharma Science Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA201087
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC] and 4 more
Marketing start Jun 27, 2022
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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