NDC Code(s) : 55154-3624-0, 55154-3613-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cytotecmisoprostol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3624(NDC:0025-1451)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
misoprostol(UNII: 0E43V0BB57)
(misoprostol - UNII:0E43V0BB57) 		misoprostol100 ug
Inactive Ingredients
Ingredient Name Strength
hydrogenated castor oil(UNII: ZF94AP8MEY)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code Searle;1451
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-3624-010 in 1 BAG 27/12/1988
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
NDA NDA019268 12/27/1988 12/31/2015
Cytotecmisoprostol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3613(NDC:0025-1461)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
misoprostol(UNII: 0E43V0BB57)
(misoprostol - UNII:0E43V0BB57) 		misoprostol200 ug
Inactive Ingredients
Ingredient Name Strength
hydrogenated castor oil(UNII: ZF94AP8MEY)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score 2 pieces
Shape HEXAGON (6 SIDED) Size 9 mm
Flavor Imprint Code Searle;1461
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-3613-010 in 1 BAG 27/12/1988
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
NDA NDA019268 12/27/1988 12/31/2015

PRINCIPAL DISPLAY PANEL

Cytotec®

Misoprostol Tablets

100 mcg

10 Tablets

Bag Label

PRINCIPAL DISPLAY PANEL

Cytotec®

Misoprostol Tablets

200 mcg

10 Tablets

Bag Label