NDC Code(s) : 68462-225-17, 68462-225-55
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mometasone FuroateMometasone furoate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-225
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-225-1715 g in 1 TUBE Type 0: Not a Combination Product28/05/2008
2NDC:68462-225-5545 g in 1 TUBE Type 0: Not a Combination Product28/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078571 05/28/2008

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 676115028 ANALYSIS(68462-225), MANUFACTURE(68462-225)

PRINCIPAL DISPLAY PANEL

NDC 68462-225-55
Mometasone Furoate Ointment USP, 0.1%
For topical use only. Not for opthalmic use.

image-01

PRINCIPAL DISPLAY PANEL

NDC 68462-225-55
Mometasone Furoate Ointment USP, 0.1%
For topical use only. Not for opthalmic use.

image-02