Chateal EQ (Page 7 of 7)

Chateal EQ .15/0.03mg Tablets 28-Day Regimen

Label Image
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CHATEAL EQ levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-2683(NDC:50102-230)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-2683-1 1 KIT in 1 BLISTER PACK None
2 NDC:53002-2683-3 3 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-2683-3)
3 NDC:53002-2683-6 6 BLISTER PACK in 1 POUCH contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-2683-6)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
CHATEAL EQ levonorgestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Biconvex, Beveled Edge) Size 6mm
Flavor Imprint Code S;44
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206866 09/23/2016
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN Score no score
Shape ROUND (Mottled, Biconvex, Beveled Edge) Size 6mm
Flavor Imprint Code S;61
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206866 09/23/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206866 09/23/2016
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-2683)

Revised: 06/2023 RPK Pharmaceuticals, Inc.

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