NDC 54569-1125-0
API & Excipient Details

Nystatin marketed by A-S Medication Solutions LLC under NDC Code 54569-1125-0

NDC Code(s) : 54569-1125-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nystatinnystatin CREAM

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:54569-1125(NDC:0603-7818)
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NYSTATIN(UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SORBIC ACID(UNII: X045WJ989B)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PETROLATUM(UNII: 4T6H12BN9U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE(UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54569-1125-0	1 in 1 CARTON
1		15 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065315	05/31/2006

PRINCIPAL DISPLAY PANEL

NDC 54569-1125-0

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048