NDC product

Ketoconazole

NDC 0093-3219 · Teva Pharmaceuticals USA, Inc.

Key facts

Product NDC 0093-3219
Proprietary name Ketoconazole
Nonproprietary name Ketoconazole
Substances KETOCONAZOLE
Dosage form CREAM
Route TOPICAL
Labeler Teva Pharmaceuticals USA, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA075581
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
Marketing start Feb 8, 2019
Listing certified through Dec 31, 2026

At a glance

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About National Drug Codes (NDC)

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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