Kelnor 1/50 (Page 8 of 8)

Package/Label Display Panel

NDC 0093-8073-16

6 Blister Card Dispensers, 28 Tablets Each

Kelnor 1/50(ethynodiol diacetate and ethinyl estradiol tablets USP)

1
(click image for full-size original)

KELNOR 1/50 ethynodiol diacetate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8073
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-8073-16 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0093-8073-28)
1 NDC:0093-8073-28 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (0093-8073-16)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
KELNOR 1/50 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 50 ug
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POVIDONE K30
D&C RED NO. 30
D&C YELLOW NO. 10
Product Characteristics
Color pink Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WATSON;384
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072723 03/01/2018
Part 2 of 2
PLACEBO placebo tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WATSON;P
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072723 03/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072723 03/01/2018
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2021 Teva Pharmaceuticals USA, Inc.

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