VIORELE (Page 11 of 11)

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carton
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VIORELE
desogestrel and ethinyl estradiol and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-318
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-318-29 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68462-318-29)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 2
Part 3 5
Part 1 of 3
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 0.02 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
STARCH, POTATO
POVIDONE K30
ISOPROPYL ALCOHOL
SILICON DIOXIDE
MAGNESIUM STEARATE
LACTOSE, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code C1;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091346 04/04/2012
Part 2 of 3
INERT
inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
TALC
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code C3;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091346 04/04/2012
Part 3 of 3
ETHINYL ESTRADIOL
ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.01 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
LACTOSE, UNSPECIFIED FORM
STARCH, POTATO
POVIDONE K30
ISOPROPYL ALCOHOL
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code C2;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091346 04/04/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091346 04/04/2012
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (68462-318), ANALYSIS (68462-318)

Revised: 02/2023 Glenmark Pharmaceuticals Inc., USA

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