HAILEY Fe 1/20 (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
(click image for full-size original)
HAILEY FE 1/20 norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-419
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-419-29 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68462-419-29)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
HAILEY FE 1/20 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
LACTOSE MONOHYDRATE
STARCH, CORN
SUCROSE
ACACIA
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (to off white) Score no score
Shape ROUND (flat faced, beveled edge) Size 6mm
Flavor Imprint Code 16;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206597 11/21/2017
Part 2 of 2
INERT ferrous fumarate tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
Product Characteristics
Color BROWN (to dark brown) Score no score
Shape ROUND (flat faced, beveled edge) Size 7mm
Flavor Imprint Code 17;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206597 11/21/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206597 11/21/2017
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-419), MANUFACTURE (68462-419)

Revised: 06/2022 Glenmark Pharmaceuticals Inc., USA

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