NDC Code(s) : 0054-4146-22, 0054-4146-23, 0054-8146-22
Packager : Hikma Pharmacuticals USA USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ClotrimazoleClotrimazole LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-4146
Route of Administration ORAL, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE(UNII: G07GZ97H65)
(CLOTRIMAZOLE - UNII:G07GZ97H65) 		CLOTRIMAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DEXTRATES(UNII: G263MI44RU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 16 mm
Flavor Imprint Code 54;552
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0054-4146-2270 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/07/2004
2NDC:0054-4146-23140 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/07/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076387 07/29/2004
ClotrimazoleClotrimazole LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-8146
Route of Administration ORAL, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE(UNII: G07GZ97H65)
(CLOTRIMAZOLE - UNII:G07GZ97H65) 		CLOTRIMAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DEXTRATES(UNII: G263MI44RU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 16 mm
Flavor Imprint Code 54;552
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0054-8146-2270 in 1 CARTON 29/07/2004
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076387 07/29/2004

LABELER - Hikma Pharmacuticals USA USA Inc.(080189610)

Establishment
Name Address ID/FEI Business Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE(0054-4146, 0054-8146)

PRINCIPAL DISPLAY PANEL

bottle label image

PRINCIPAL DISPLAY PANEL

folding carton image