ALYACEN 1/35 (Page 9 of 9)

Alyacen 1/35 Tablets 28-Day Regimen

Label Image
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ALYACEN 1/35 norethindrone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1780(NDC:68462-394)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1780-1 1 KIT in 1 BLISTER PACK None
2 NDC:53002-1780-6 6 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1780-6)
3 NDC:53002-1780-3 3 BLISTER PACK in 1 POUCH contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1780-3)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
ALYACEN 1/35 norethindrone and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C YELLOW NO. 6
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TALC
Product Characteristics
Color PINK (peach) Score no score
Shape ROUND (flat faced, beveled edged) Size 7mm
Flavor Imprint Code A1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091634 01/19/2012
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 2
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color GREEN (light green) Score no score
Shape ROUND (flat faced, beveled edged) Size 7mm
Flavor Imprint Code A2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091634 01/19/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091634 01/19/2012
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1780)

Revised: 06/2023 RPK Pharmaceuticals, Inc.

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