NDC 0168-0099

ketoconazole 20 mg per 1 g cream

Where it's made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants E. FOUGERA & CO., A division of Nycomed US Inc. names for other drugs.

Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Nov 18, 2013 · Class III · Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Lots: Lot #: 495P, Exp 07/14
Jul 18, 2012 · Class III · Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Lots: Lot #: 835H, Exp 07/12

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Ketoconazole: every company that makes it
Form: cream, topical
Strength: 20 mg per 1 g
Approval: ANDA ANDA076294
On the market since: Apr 28, 2004
Package NDCs: 0168-0099-15 0168-0099-30 0168-0099-60
Official label: DailyMed (National Library of Medicine), updated Jan 28, 2026

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?