Ketoconazole

Product NDC

50090-3299

11-digit product format

500903299

Labeler code

50090

Product ID

50090-3299_e2e1bd73-e447-4b0b-a6ab-f3262509aff6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ketoconazole

Dosage form

CREAM

Route

TOPICAL

Labeler

A-S Medication Solutions

Application

ANDA075581

Marketing category

ANDA

Marketing start

2015-06-15

Marketing end

0000-00-00

Substance

KETOCONAZOLE

Active strength

20 mg/g

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record