Tri Femynor (Page 9 of 9)

norgestimate and ethinyl estradiol

Label ImageLabel Image
TRI FEMYNOR
norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3239(NDC:69238-1607)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3239-0 1 KIT in 1 KIT None
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
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
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
LACTOSE MONOHYDRATE
POLACRILIN POTASSIUM
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
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
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 — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3239)

Revised: 04/2021 A-S Medication Solutions

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