Mfd. for:
Janssen Pharmaceuticals, Inc.
Titusville, New Jersey 08560

© Janssen 1998

 
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INGREDIENTS AND APPEARANCE
ORTHO TRI CYCLEN 
norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-191
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50458-191-15 6 in 1 CARTON 12/29/1989 
1 NDC:50458-191-00 1 in 1 BLISTER PACK; Type 0: Not a Combination Product  
2 NDC:50458-191-20 48 in 1 CARTON 12/29/1989 
2  1 in 1 DIALPACK; Type 0: Not a Combination Product  
3 NDC:50458-191-12 12 in 1 CARTON 12/29/1989 
3  1 in 1 DIALPACK; Type 0: Not a Combination Product  
 
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1  7 
Part 2  7 
Part 3  7 
Part 4  7 
 
Part 1 of 4
ORTHO TRI CYCLEN 
norgestimate and ethinyl estradiol tablet, coated
 
Product Information

Route of Administration ORAL
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
norgestimate (UNII: C291HFX4DY) (norgestimate - UNII:C291HFX4DY) norgestimate 0.180 mg
ethinyl estradiol (UNII: 423D2T571U) (ethinyl estradiol - UNII:423D2T571U) ethinyl estradiol 0.035 mg
 
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax (UNII: R12CBM0EIZ)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Hypromelloses (UNII: 3NXW29V3WO)  
Lactose (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Water (UNII: 059QF0KO0R)  
 
Product Characteristics
Color WHITE Score no score
Shape ROUND (BICONVEX) Size 6mm
Flavor  Imprint Code O;180;35
Contains     
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019653 12/29/1989 
 
Part 2 of 4
ORTHO TRI CYCLEN 
norgestimate and ethinyl estradiol tablet, coated
 
Product Information

Route of Administration ORAL
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
norgestimate (UNII: C291HFX4DY) (norgestimate - UNII:C291HFX4DY) norgestimate 0.215 mg
ethinyl estradiol (UNII: 423D2T571U) (ethinyl estradiol - UNII:423D2T571U) ethinyl estradiol 0.035 mg
 
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 2 (UNII: L06K8R7DQK)  
Aluminum Oxide (UNII: LMI26O6933)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Hypromelloses (UNII: 3NXW29V3WO)  
Lactose (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyethylene Glycols (UNII: 3WJQ0SDW1A)