Fyavolv (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

0.5 mg/0.0025 mg

Rx Only

Wallet and Pouch Label: 28 Tablets — NDC 68180-827-11

Carton Label: 3 Wallets of 28 Tablets Each — NDC 68180-827-13

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

0.5 mg/0.0025 mg

Rx Only

NDC 68180-827-09

Bottle Label: 90 Tablets

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

1 mg/0.005 mg

Rx Only

Wallet and Pouch Label: 28 Tablets — NDC 68180-828-11

Carton Label: 3 Wallets of 28 Tablets Each — NDC 68180-828-13

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

1 mg/0.005 mg

Rx Only

NDC 68180-828-09

Bottle Label: 90 Tablets

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

0.5 mg/0.0025 mg

Rx Only

Blister and Pouch Label: 28 Tablets — NDC 68180-827-71

Carton Label: 3 Blister of 28 Tablets Each — NDC 68180-827-73

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

1 mg/0.005 mg

Rx Only

Blister and Pouch Label: 28 Tablets — NDC 68180-828-71

Carton Label: 3 Blister of 28 Tablets Each — NDC 68180-828-73

FYAVOLV norethindrone acetate and ethinyl estradiol tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-827 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.0025 mg NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 0.5 mg

Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MONOHYDRATE POLYETHYLENE GLYCOL 400 STARCH, CORN TITANIUM DIOXIDE TOCOPHEROL

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (round) Size 6mm Flavor Imprint Code LU;F51 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-827-73 3 POUCH in 1 CARTON contains a POUCH (68180-827-71) 1 NDC:68180-827-71 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-827-73) and contains a BLISTER PACK 1 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-827-71) and a CARTON (68180-827-73) 2 NDC:68180-827-13 3 POUCH in 1 CARTON contains a POUCH (68180-827-11) 2 NDC:68180-827-11 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-827-13) and contains a BLISTER PACK 2 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-827-11) and a CARTON (68180-827-13) 3 NDC:68180-827-09 1 BOTTLE in 1 CARTON contains a BOTTLE 3 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68180-827-09)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204213 03/15/2016

FYAVOLV norethindrone acetate and ethinyl estradiol tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-828 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.005 mg NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg

Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE POLYETHYLENE GLYCOL 400 STARCH, CORN TITANIUM DIOXIDE TOCOPHEROL

Product Characteristics Color BLUE (Blue) Score no score Shape ROUND (round) Size 6mm Flavor Imprint Code LU;F52 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-828-73 3 POUCH in 1 CARTON contains a POUCH (68180-828-71) 1 NDC:68180-828-71 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-828-73) and contains a BLISTER PACK 1 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-828-71) and a CARTON (68180-828-73) 2 NDC:68180-828-13 3 POUCH in 1 CARTON contains a POUCH (68180-828-11) 2 NDC:68180-828-11 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-828-13) and contains a BLISTER PACK 2 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-828-11) and a CARTON (68180-828-13) 3 NDC:68180-828-09 1 BOTTLE in 1 CARTON contains a BOTTLE 3 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68180-828-09)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204213 03/15/2016

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		650582310	MANUFACTURE (68180-827), MANUFACTURE (68180-828)

Revised: 08/2021 Lupin Pharmaceuticals, Inc.