Norelgestromin

FDA Drug Profile

Norelgestromin is listed in the FDA National Drug Code directory with 2 NDC codes. Available dosage form: powder.

Drug Details

Generic Name
Norelgestromin
Brand Names
N/A
Application Number
Sponsor
Gedeon Richter Plc.
NDC Codes
2
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
NORELGESTROMIN

Indications and Usage

1 INDICATIONS AND USAGE Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m 2 [see Contraindications (4) , Warnings and Precautions (5.1) and Clinical Studies (14) ] . Xulane is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 ) Limitations of Use: Xulane may be less effective in preventing pregnancy in women at or above 198 lbs. (90 kg). ( 1 , 4 , 14 )