Kelnor 1/35 (Page 8 of 8)

Package/Label Display Panel, Part 1 of 2

NDC 0555-9064-58

6 Blister Card Dispensers, 28 Tablets Each

28

DAY

REGIMEN

Kelnor® 1/35

(ethynodiol diacetate and

ethinyl estradiol tablets USP)

Contains 6 blister cards, each containing 28 tablets. Each light yellow

tablet contains 1 mg ethynodiol diacetate, USP and 35 mcg ethinyl

estradiol, USP. Each white tablet contains inert ingredients.

Rx only

SHAPING

WOMEN’S HEALTH®

1
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Package/Label Display Panel, Part 2 of 2

2
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KELNOR 1/35 ethynodiol diacetate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-9064
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-9064-58 6 POUCH in 1 CARTON contains a POUCH (0555-9064-79)
1 NDC:0555-9064-79 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0555-9064-58) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (0555-9064-79) and a CARTON (0555-9064-58)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ethynodiol diacetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHYNODIOL DIACETATE (ETHYNODIOL) ETHYNODIOL DIACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 35 ug
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
D&C YELLOW NO. 10 ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POVIDONE K90
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;14
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076785 06/20/2005
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2208 (3 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;143
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076785 06/20/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076785 06/20/2005
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 10/2022 Teva Pharmaceuticals USA, Inc.

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