ketoconazole

Product NDC
63629-9421
11-digit product format
636299421
Labeler code
63629
Product ID
63629-9421_b70b2009-fe86-42f7-b066-c8332c92edf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA091550
Marketing category
ANDA
Marketing start
2011-08-30
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
2 g/100g
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9421-1GM - Gram63629-9421ae7e7fda-f7dc-463e-bca5-c3765364f1c812022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9421-1636299421011 CANISTER in 1 CARTON (63629-9421-1) > 50 g in 1 CANISTER1 canister2022-08-230000-00-00NoNoCurrent