NDC 0168-0099 – Ketoconazole
Ketoconazole 20 mg/g · Cream · Topical
Product NDC0168-0099
Product details
- Brand name
- Ketoconazole
- Generic name
- Ketoconazole
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Dosage form
- Cream
- Route
- Topical
- Marketing category
- ANDA · ANDA076294
- Marketed since
- April 28, 2004
- Listing expires
- December 31, 2027
- Pharmacologic class
- Azole Antifungal
Active ingredients
- Ketoconazole 20 mg/g
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0168-0099-15 | 1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE | Apr 28, 2004 |
| 0168-0099-30 | 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE | Apr 28, 2004 |
| 0168-0099-60 | 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE | Apr 28, 2004 |
Recalls mentioning this NDC
- D-1065-2022 Jun 15, 2022 · Class II
cGMP deviations: Temperature abuse - D-1044-2014 Feb 5, 2014 · Class III
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. - D-241-2013 Apr 10, 2013 · Class III
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
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