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NDC 70518-0915-01 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 REMEDYREPACK INC.. 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: 70518-0915-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketoconazole

Product Information

NDC	70518-0915
Product ID	70518-0915_088d558e-3097-61a6-e063-6294a90aa695
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	REMEDYREPACK INC.
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	ANDA075319
Listing Certified Through	2024-12-31

Package

NDC 70518-0915-01 (70518091501)

Pricing Information	N/A
NDC Package Code	70518-0915-1
Billing NDC	70518091501
Package	7 TABLET in 1 BOTTLE, PLASTIC (70518-0915-1)
Marketing Start Date	2018-02-10
NDC Exclude Flag	N