NDC product

ezetimibe and simvastatin

NDC 68462-321 · Glenmark Pharmaceuticals Inc., USA

Key facts

Product NDC 68462-321
Proprietary name ezetimibe and simvastatin
Nonproprietary name ezetimibe and simvastatin
Substances EZETIMIBE, SIMVASTATIN
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA208699
Pharmacologic classes Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
Marketing start Jun 27, 2019
Listing certified through Dec 31, 2026

At a glance

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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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