Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Product Details
NDC Product Code
68788-8845Application Number
M005Marketing Category
OTC Monograph Drug (C200263)Route of Administration
TOPICALEffective Date
March 24, 2025MiconazoleActive
Code: VW4H1CYW1KClass: ACTIBQuantity: 2 g in 100 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FCClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698HClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
ETHYLPARABENInactive
Code: 14255EXE39Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GLYCERYL DISTEARATEInactive
Code: 73071MW2KMClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUYClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT