NDC Code(s) : 0115-1470-52, 0115-1470-46
Packager : Impax Generics

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mometasone FuroateMometasone Furoate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1470
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOMETASONE FUROATE(UNII: 04201GDN4R)
(MOMETASONE - UNII:8HR4QJ6DW8) 		MOMETASONE FUROATE1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
PHOSPHORIC ACID(UNII: E4GA8884NN)
PROPYLENE GLYCOL MONOPALMITOSTEARATE(UNII: F76354LMGR)
WHITE WAX(UNII: 7G1J5DA97F)
PETROLATUM(UNII: 4T6H12BN9U)
WATER(UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1470-521 in 1 CARTON
115 g in 1 TUBE Type 0: Not a Combination Product
2NDC:0115-1470-461 in 1 CARTON
245 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076591 04/18/2007

PRINCIPAL DISPLAY PANEL

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