XULANE (Page 11 of 11)

norelgestromin and ethinyl estradiol

Label ImageLabel Image
XULANE
norelgestromin and ethinyl estradiol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1683(NDC:0378-3340)
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORELGESTROMIN (NORELGESTROMIN) NORELGESTROMIN 150 ug in 1 d
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 35 ug in 1 d
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
MINERAL OIL
OLEYL ALCOHOL
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1683-0 3 POUCH in 1 CARTON contains a POUCH
1 1 d in 1 POUCH This package is contained within the CARTON (50090-1683-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200910 04/16/2014
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1683)

Revised: 12/2017 A-S Medication Solutions

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