Junel Fe 28 Day (Page 10 of 10)

Package/Label Display Panel

NDC 68788-8114-1

6 Cyclic Tablet Dispensers x 28 Tablets

28

DAY

REGIMEN

Junel® Fe 1.5/30

(norethindrone acetate and

ethinyl estradiol tablets, USP

and ferrous fumarate tablets*)

Contains 6 blister cards, each containing 28 tablets. Each pink tablet

contains norethindrone acetate, 1.5 mg; ethinyl estradiol, 30 mcg.

Each brown tablet contains ferrous fumarate, USP, 75 mg.

Each tablet dispenser contains 21 pink tablets and 7 brown tablets.

*Ferrous fumarate tablets are not USP for dissolution and assay.

Rx only

SHAPING

WOMEN’S HEALTH®

JUNEL FE 28 DAY norethindrone acetate and ethinyl estradiol and ferrous fumarate kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8113(NDC:0555-9028)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68788-8113-2 1 BLISTER PACK in 1 POUCH contains a BLISTER PACK 1 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (68788-8113-2)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 21 Part 2 7

Part 1 of 2 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1.5 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 30 ug

Inactive Ingredients Ingredient Name Strength ACACIA SUCROSE MALTODEXTRIN FD&C RED NO. 40 LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN

Product Characteristics Color pink Score no score Shape ROUND Size 6mm Flavor Imprint Code b;978 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076064 12/06/2021

Part 2 of 2 INERT inert tablet

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE FERROUS FUMARATE HYDROGENATED COTTONSEED OIL MICROCRYSTALLINE CELLULOSE

Product Characteristics Color brown Score no score Shape ROUND Size 6mm Flavor Imprint Code b;247 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076064 12/06/2021

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076064 12/06/2021

Labeler — Preferred Pharmaceuticals Inc. (791119022)

Registrant — Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL (68788-8113)

Revised: 12/2021 Preferred Pharmaceuticals Inc.