KETOCONAZOLE 200 mg/1
ketoconazole · TABLET · Bryant Ranch Prepack
KETOCONAZOLE is a tablet containing ketoconazole at 200 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- KETOCONAZOLE
- Generic Name
- ketoconazole
- NDC Code (Product)
71335-1849- Manufacturer
- Bryant Ranch Prepack
- Strength
- 200 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075912
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 04/10/2020
Recall History
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Tolmar, Inc.
Subpotent
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
ALMIRALL, LLC
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Frequently Asked Questions
What is KETOCONAZOLE used for?
KETOCONAZOLE contains ketoconazole. It is a tablet taken oral. Consult your doctor for specific uses.
Is KETOCONAZOLE a controlled substance?
KETOCONAZOLE is not classified as a controlled substance by the DEA.
What is the generic name for KETOCONAZOLE?
The generic name for KETOCONAZOLE is ketoconazole. There are 10 other brand versions of ketoconazole.
What is the NDC code for KETOCONAZOLE 200 mg/1?
The NDC (National Drug Code) for KETOCONAZOLE 200 mg/1 is 71335-1849, listed by Bryant Ranch Prepack.
Other KETOCONAZOLE Dosages
Other Ketoconazole Brands
See all →- Gembooxt Ketoconazole 1% Medicated Shampoos.01 g/mL76986-025
- Ketoconazole20 mg/g87063-066
- Ketoconazole20 mg/mL50090-3288
- Ketoconazole20 mg/mL63646-010
- Ketoconazole20 mg/mL70771-1874
- ketoconazole2 g/100g71335-2943
- Ketoconazole20 mg/g82804-091
- Nizoral10 mg/mL55505-196
- Nizoral1 g/100mL55505-232
- Ketoconazole20 mg/g68071-1709
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)