Bekyree (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bekyree™

desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP,0.01 mg

NDC 68180-880-11

Wallet Label: 28 Tablets

Bekyree™

desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP,0.01 mg

NDC 68180-880-11

Pouch Label: 1 Wallet of 28 Tablets

Bekyree™

desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP,0.01 mg

NDC 68180-880-13

Carton Label: 3 Wallets of 28 Tablets each

BEKYREE desogestrel and ethinyl estradiol and ethinyl estradiol kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-880

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-880-13 3 POUCH in 1 CARTON contains a POUCH (57297-880-11) 1 NDC:57297-880-11 1 KIT in 1 POUCH This package is contained within the CARTON (57297-880-13)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 21 Part 2 2 Part 3 5

Part 1 of 3 BEKYREE desogestrel and ethinyl estradiol tablet, film coated

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 DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POVIDONES SILICON DIOXIDE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE TOCOPHEROL

Product Characteristics Color WHITE (white) Score no score Shape ROUND (Biconvex) Size 5mm Flavor Imprint Code LU;K21 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202226 10/26/2015

Part 2 of 3 BEKYREE inert tablet, film coated

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 STARCH, CORN TITANIUM DIOXIDE

Product Characteristics Color GREEN (green) Score no score Shape ROUND (BICONVEX) Size 5mm Flavor Imprint Code LU;L22 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202226 10/26/2015

Part 3 of 3 BEKYREE ethinyl estradiol tablet, film coated

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.01 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POVIDONES SILICON DIOXIDE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE TOCOPHEROL ALUMINUM OXIDE

Product Characteristics Color YELLOW (yellow) Score no score Shape ROUND (biconvex) Size 5mm Flavor Imprint Code LU;K22 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202226 10/26/2015

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202226 10/26/2015

Labeler — LUPIN LIMITED (675923163)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		650582310	manufacture (57297-880), pack (57297-880)

Revised: 05/2016 LUPIN LIMITED