ketoconazole

NDC 0168-0099 · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Generic nameketoconazole

Dosage formCREAM

RouteTOPICAL

Active ingredient(s)KETOCONAZOLE

Strength20 mg/g

Pharmacologic classAzole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

Marketing categoryANDA

Packages

0168-0099-15 — 1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE

0168-0099-30 — 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE

0168-0099-60 — 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0093-3219 — Ketoconazole, 0713-0592 — Ketoconazole, 16714-955 — Ketoconazole, 21922-025 — Ketoconazole Cream, 2%, 35573-433 — ketoconazole, 43538-530 — ketoconazole, 45802-465 — Ketoconazole, 45802-532 — ketoconazole, 50090-3288 — Ketoconazole, 50090-5265 — Ketoconazole, 50090-6046 — Ketoconazole Cream, 2%, 50090-6069 — Ketoconazole, 50090-6142 — ketoconazole, 50090-7538 — Ketoconazole, 51407-279 — Ketoconazole, 51672-1298 — Ketoconazole, 51672-4026 — Ketoconazole, 55505-196 — Ketoconazole, 55505-232 — Ketoconazole, 55505-233 — Ketoconazole, +49 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.