Nortrel 28 Day (Page 9 of 9)

Norethindrone and Ethinyl Estradiol

Label ImageLabel Image
NORTREL 28 DAY norethindrone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3229(NDC:0555-9008)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3229-0 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
NORETHINDRONE AND ETHINYL ESTRADIOL 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 0.5 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10 ALUMINUM LAKE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;941
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072695 06/06/2001
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;944
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072695 06/06/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072695 06/06/2001
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3229), REPACK (50090-3229)

Revised: 02/2023 A-S Medication Solutions

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