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NDC 64380-0827-07 KETOCONAZOLE 200 mg/1 Details

KETOCONAZOLE 200 mg/1

KETOCONAZOLE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is KETOCONAZOLE.

MedlinePlus Drug Summary

Ketoconazole is used to treat fungal infections when other medications are not available or cannot be tolerated. Ketoconazole should not be used to treat fungal meningitis (infection of the membranes surrounding the brain and spinal cord caused by a fungus) or fungal nail infections. Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.

Related Packages: 64380-0827-07
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketoconazole

Product Information

NDC	64380-0827
Product ID	64380-827_bf07547c-c86d-404d-90ef-9aaf3636783b
Associated GPIs	11404040000310
GCN Sequence Number	009544
GCN Sequence Number Description	ketoconazole TABLET 200 MG ORAL
HIC3	W3B
HIC3 Description	ANTIFUNGAL AGENTS
GCN	42590
HICL Sequence Number	004132
HICL Sequence Number Description	KETOCONAZOLE
Brand/Generic	Generic
Proprietary Name	KETOCONAZOLE
Proprietary Name Suffix	n/a
Non-Proprietary Name	KETOCONAZOLE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	KETOCONAZOLE
Labeler Name	Strides Pharma Science Limited
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210457
Listing Certified Through	2024-12-31

Package

NDC 64380-0827-07 (64380082707)

Pricing Information	N/A
NDC Package Code	64380-827-07
Billing NDC	64380082707
Package	500 TABLET in 1 BOTTLE (64380-827-07)
Marketing Start Date	2018-06-26
NDC Exclude Flag	N