Tri Femynor (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

blister
(click image for full-size original)

carton
(click image for full-size original)
TRI FEMYNOR
norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1607
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1607-6 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (69238-1607-6)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 3 21
Part 4 21
Part 1 of 4
TRI FEMYNOR
norgestimate and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.18 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYDROGENATED COTTONSEED OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (light pink) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code E1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203870 10/28/2016
Part 2 of 4
INERT
inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED COTTONSEED OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code C2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203870 10/28/2016
Part 3 of 4
TRI FEMYNOR
norgestimate and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.215 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYDROGENATED COTTONSEED OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color RED (light red) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code E2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203870 10/28/2016
Part 4 of 4
TRI FEMYNOR
norgestimate and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.25 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYDROGENATED COTTONSEED OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape ROUND Size 6mm
Flavor Imprint Code E3
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203870 10/28/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203870 10/28/2016
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 05/2019 Amneal Pharmaceuticals NY LLC

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