Apri 28 Day (Page 8 of 8)

Package/Label Display Panel, Part 1 of 2

Apri® (desogestrel and ethinyl estradiol tablets USP) 0.15 mg/0.03 mg, 6 Cyclic Dispensers, 28 Tablets Each, Carton, Part 1 of 2
(click image for full-size original)

Package/Label Display Panel, Part 2 of 2

Apri® (desogestrel and ethinyl estradiol tablets USP) 0.15 mg/0.03 mg, 6 Cyclic Dispensers, 28 Tablets Each, Carton, Part 2 of 2
(click image for full-size original)

Apri® (desogestrel and ethinyl estradiol tablets USP) 0.15 mg/0.03 mg, 6 Cyclic Dispensers, 28 Tablets Each, Carton Text

NDC 0555-9043 -58

28

DAY

REGIMEN

6 Cyclic Tablet Dispensers x 28 Tablets

Apri ®

(desogestrel and

ethinyl estradiol tablets USP)

0.15 mg/0.03 mg

Each rose-colored tablet contains 0.15 mg desogestrel and 0.03 mg

ethinyl estradiol, USP. Each white tablet contains inert ingredients.

Rx only

SHAPING

WOMEN’S HEALTH®

TEVA

APRI 28 DAY desogestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-9043
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-9043-58 6 POUCH in 1 CARTON contains a POUCH (0555-9043-79)
1 NDC:0555-9043-79 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0555-9043-58) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (0555-9043-79) and a CARTON (0555-9043-58)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
DESOGESTREL AND ETHINYL ESTRADIOL 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
DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
FD&C RED NO. 40
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYSORBATE 80
POVIDONE K30
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
ALPHA-TOCOPHEROL
Product Characteristics
Color RED (rose-colored) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code dp;575
Contains
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075256 10/22/1999
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code dp;570
Contains
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075256 10/22/1999
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075256 10/22/1999
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 08/2018 Teva Pharmaceuticals USA, Inc.

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