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 1.5/30
(click image for full-size original)
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.

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