norelgestromin and ethinyl estradiol
norelgestromin and ethinyl estradiol is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including XULANE, norelgestromin and ethinyl estradiol, Gwyn Lo. Available dosage form: patch.
Drug Details
- Generic Name
- norelgestromin and ethinyl estradiol
- Brand Names
- XULANE, norelgestromin and ethinyl estradiol, Gwyn Lo
- Application Number
- ANDA200910
- Sponsor
- A-S Medication Solutions
- NDC Codes
- 5
- Dosage Forms
- PATCH
- Routes
- TRANSDERMAL
- Active Ingredients
- NORELGESTROMIN, ETHINYL ESTRADIOL
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 )