Tarina Fe 1/20 EQ (Page 8 of 8)

Tarina Fe 1/20 EQ Tablets 28-Day Regimen

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TARINA FE 1/20 EQ norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-3711(NDC:50102-228)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-3711-1 1 KIT in 1 BLISTER PACK None
2 NDC:53002-3711-3 3 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-3711-3)
3 NDC:53002-3711-6 6 BLISTER PACK in 1 POUCH contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-3711-6)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
TARINA FE 1/20 EQ norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
.ALPHA.-TOCOPHEROL
Product Characteristics
Color YELLOW (Light yellow to yellow) Score no score
Shape ROUND (Flat Faced, Beveled Edge) Size 6mm
Flavor Imprint Code S;64
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207505 06/16/2017
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE 75 mg
SPEARMINT
SUCRALOSE
Product Characteristics
Color BROWN Score no score
Shape ROUND (Mottled, Flat Faced, Beveled Edge) Size 6mm
Flavor Imprint Code S;57
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207505 06/16/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207505 06/16/2017
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-3711)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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