norethindrone acetate and ethinyl estradiol
norethindrone acetate and ethinyl estradiol is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including Blisovi Fe 1/20, Jinteli, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. Available dosage forms: kit, tablet.
Drug Details
- Generic Name
- norethindrone acetate and ethinyl estradiol
- Brand Names
- Blisovi Fe 1/20, Jinteli, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, LUIZZA 1.5/30, BLISOVI FE 1.5/30, LUIZZA 1/20, Blisovi 24 Fe
- Application Number
- ANDA201584
- Sponsor
- Lupin Pharmaceuticals, Inc.
- NDC Codes
- 11
- Dosage Forms
- KIT, TABLET
- Routes
- ORAL
- Active Ingredients
- NORETHINDRONE ACETATE, ETHINYL ESTRADIOL
Indications and Usage
1 INDICATION S AND USAGE TAYTULLA is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. TAYTULLA is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) The efficacy of TAYTULLA in females of reproductive potential with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated ( 1 , 8.8 )