Minastrin 24 Fe (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Minastrin 24 Fe
1 mg/ 20 mcg
chewable
28 Day RegimenRx Only

PRINCIPAL DISPLAY PANEL Minastrin 24 Fe 1 mg/ 20 mcg chewable 28 Day Regimen Rx Only
(click image for full-size original)

MINASTRIN 24 FE norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0540
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0430-0540-50 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (0430-0540-50)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 4
Part 2 24
Part 1 of 2
MINASTRIN 24 FE ferrous fumarate tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE
MANNITOL
POVIDONE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
MAGNESIUM STEARATE
SUCRALOSE
SPEARMINT
Product Characteristics
Color brown Score no score
Shape ROUND Size 6mm
Flavor SPEARMINT Imprint Code WC;624
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203667
Part 2 of 2
MINASTRIN 24 FE norethindrone acetate and ethinyl estradiol tablet, chewable
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
ACACIA
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
STARCH, CORN
TALC
SUCRALOSE
SPEARMINT
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor SPEARMINT Imprint Code WC;535
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203667
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203667 06/14/2013
Labeler — Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Teva Puerto Rico LLC 152356536 analysis (0430-0540), manufacture (0430-0540), pack (0430-0540)

Revised: 04/2022 Allergan, Inc.

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