Norethindrone Acetate and Ethinyl Estradiol (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

NDC 69238-1582-3

Rx only

Carton Label Amneal Pharmaceuticals LLC

4
(click image for full-size original)
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1582
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1582-3 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (69238-1582-9)
1 NDC:69238-1582-9 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (69238-1582-3)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 24
Part 2 4
Part 1 of 2
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 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 20 ug
Inactive Ingredients
Ingredient Name Strength
POVIDONE
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code AL1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078267 12/20/2013
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE 75 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS LACTOSE
CROSPOVIDONE (12 MPA.S AT 5%)
MAGNESIUM STEARATE
Product Characteristics
Color brown Score no score
Shape ROUND Size 6mm
Flavor Imprint Code AL2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078267 12/20/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078267 12/20/2013
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 07/2023 Amneal Pharmaceuticals NY LLC

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