Blisovi 24 Fe: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blisovi™ 24 Fe [norethindrone acetate and ethinyl estradiol tablets USP, (1 mg/0.02 mg) and ferrous fumarate tablets, (75 mg)]

Rx only

NDC 68180-864-71

Blister Label: 28 Tablets

Blisovi™ 24 Fe [norethindrone acetate and ethinyl estradiol tablets USP, (1 mg/0.02 mg) and ferrous fumarate tablets, (75 mg)]

Rx only

NDC 68180-864-71

Pouch Label: 1 blister of 28 Tablets

Blisovi™ 24 Fe [norethindrone acetate and ethinyl estradiol tablets USP, (1 mg/0.02 mg) and ferrous fumarate tablets, (75 mg)]

Rx only

NDC 68180-864-73

Carton Label: 3 blisters of 28 Tablets

BLISOVI 24 FE norethindrone acetate and ethinyl estradiol kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-864

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-864-73 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68180-864-71) 1 NDC:68180-864-71 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68180-864-73)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 24 Part 2 4

Part 1 of 2 BLISOVI 24 FE norethindrone acetate and ethinyl estradiol tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg

Inactive Ingredients Ingredient Name Strength ACACIA LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SUCROSE TALC

Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND (round; flat face beveled edge) Size 6mm Flavor Imprint Code LU;N21 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091398 11/07/2019

Part 2 of 2 INERT inert tablet

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE FERROUS FUMARATE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO SUCROSE

Product Characteristics Color BROWN (brown mottled) Score no score Shape ROUND (round; flat face beveled edge) Size 6mm Flavor Imprint Code LU;M22 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091398 11/07/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091398 11/07/2019

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		650582310	MANUFACTURE (68180-864)

Revised: 02/2023 Lupin Pharmaceuticals, Inc.