MERZEE: Package Insert and Label Information (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MERZEE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules)
1 mg/20 mcg

NDC 43386-371-32
28 Day Regimen
Rx Only

Merzee Carton Label
(click image for full-size original)

MERZEE norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-371
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43386-371-32 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (43386-371-32)
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 capsule, liquid filled
Product Information
Item Code (Source) NDC:71225-138
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
SESAME OIL
CORN OIL PEG-6 ESTERS
ALPHA-TOCOPHEROL
ALCOHOL
GELATIN
GLYCERIN
SORBITOL
WATER
FD&C RED NO. 40
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape OVAL Size 9mm
Flavor Imprint Code SP
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212706 03/09/2022
Part 2 of 2
FERROUS FUMARATE ferrous fumarate capsule, liquid filled
Product Information
Item Code (Source) NDC:71225-139
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE
SOYBEAN OIL
LECITHIN, SOYBEAN
YELLOW WAX
GELATIN
GLYCERIN
SORBITOL
WATER
FD&C RED NO. 40
FD&C BLUE NO. 1
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 9mm
Flavor Imprint Code SP
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212706 03/09/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212706 03/09/2022
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — Slayback Pharma LLC (967770848)
Establishment
Name Address ID/FEI Operations
NextPharma Ploermel 493010524 ANALYSIS (43386-371), MANUFACTURE (43386-371)
Establishment
Name Address ID/FEI Operations
AndersonBrecon (UK) Limited 762771269 PACK (43386-371)

Revised: 06/2022 Lupin Pharmaceuticals, Inc.

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