estradiol
estradiol is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including ESTRADIOL, Vagifem, Estradiol Vaginal. Available dosage forms: gel, insert, cream, film, extended release, patch.
Drug Details
- Generic Name
- estradiol
- Brand Names
- ESTRADIOL, Vagifem, Estradiol Vaginal, Estradiol, Minivelle, Imvexxy, estradiol, IMVEXXY, Vivelle-Dot, DIVIGEL, ESTRADIOL VAGINAL INSERTS, Estring, EstroGel, Menostar, ESTRACE
- Application Number
- ANDA216524
- Sponsor
- Bryant Ranch Prepack
- NDC Codes
- 50
- Dosage Forms
- GEL, INSERT, CREAM, FILM, EXTENDED RELEASE, PATCH, PATCH, EXTENDED RELEASE, TABLET, FILM COATED, SYSTEM, GEL, METERED
- Routes
- TOPICAL, VAGINAL, TRANSDERMAL
- Active Ingredients
- ESTRADIOL
Indications and Usage
1 INDICATIONS AND USAGE Climara is indicated for: Climara is an estrogen indicated for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) Prevention of Postmenopausal Osteoporosis ( 1.4 ) Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. 1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure 1.4 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.