Drospirenone and Ethinyl Estradiol (Page 10 of 10)

drospirenone and ethinyl estradiol

Label ImageLabel Image
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2494(NDC:68462-733)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2494-0 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
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROSPIRENONE (DROSPIRENONE) DROSPIRENONE 3 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE K25
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (light yellow to yellow) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code E5
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204848 03/25/2016
Part 2 of 2
INERT
inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code E6
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204848 03/25/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204848 03/25/2016
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2494), REPACK (50090-2494)

Revised: 09/2022 A-S Medication Solutions

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