Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-197
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50458-197-15 6 in 1 CARTON 12/29/1989
1 NDC:50458-197-00 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:50458-197-20 48 in 1 CARTON 12/29/1989
2 1 in 1 DIALPACK; Type 0: Not a Combination Product
3 NDC:50458-197-12 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 21
Part 2 7
Part 1 of 2
ORTHO 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 0.25 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)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)
Product Characteristics
Color BLUE Score no score
Shape ROUND (BICONVEX) Size 6mm
Flavor Imprint Code O;250;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 2
INERT
inert tablet, coated
Product Information
Route of Administration ORAL
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 2 (UNII: L06K8R7DQK)
Aluminum Oxide (UNII: LMI26O6933)
Ferric Oxide Red (UNII: 1K09F3G675)
Lactose (UNII: J2B2A4N98G)
Magnesium Stearate (UNII: 70097M6I30)
Polyethylene Glycols (UNII: 3WJQ0SDW1A)
Starch, Corn (UNII: O8232NY3SJ)
Polyvinyl Alcohol (UNII: 532B59J990)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)
Product Characteristics
Color GREEN (DARK GREEN) Score no score
Shape ROUND (BICONVEX) Size 6mm
Flavor Imprint Code O;M;P
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019653 12/29/1989
Marketing Information
Marketing Category Application Number or Monogra
