Junel Fe 28 Day (Page 10 of 10)

norethindrone acetate and ethinyl estradiol, and ferrous fumarate

Label ImageLabel Image
JUNEL FE 28 DAY norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3237(NDC:0555-9026)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3237-0 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 ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
SUCROSE
MALTODEXTRIN
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;977
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076081 09/18/2003
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERROUS FUMARATE
HYDROGENATED COTTONSEED OIL
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color brown Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;247
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076081 09/18/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076081 09/18/2003
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3237)

Revised: 01/2022 A-S Medication Solutions

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