Zovia 1/35 (Page 8 of 8)

Zovia 1/35E Tablets 28-Day Regimen

Label Image
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ZOVIA 1/35 ethynodiol diacetate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1591(NDC:51862-260)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1591-1 1 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (53002-1591-1)
2 NDC:53002-1591-3 3 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (53002-1591-3)
3 NDC:53002-1591-6 6 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (53002-1591-6)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ethynodiol diacetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHYNODIOL DIACETATE (ETHYNODIOL) ETHYNODIOL DIACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POVIDONE K90
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;14
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076785 07/18/2016
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (3 MPA.S)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;143
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076785 07/18/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076785 07/18/2016
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1591), REPACK (53002-1591)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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