FDA label
What is Dotti used for?
Dotti contains estradiol. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Dotti lists 4 uses: Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause; Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause; Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure; Prevention of Postmenopausal Osteoporosis.
Run it in Rivvi
Which 2027 plans near you dropped or restricted Dotti?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Dotti, patch, extended release
Indications and Usage, quoted from the label by Amneal Pharmaceuticals LLC (ANDA211293). Cross-references to other label sections are left out.
DOTTI is indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause
Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure
Prevention of Postmenopausal Osteoporosis
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.
Source: DailyMed label, set id 53016d30-6b5f-49da-ac16-85ef415a5805, version 10, effective May 14, 2024. NDC 65162-989, one of 10 listings for this product.
Questions
What is Dotti used for?
The FDA label for Dotti lists 4 uses: Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause; Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause; Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure; Prevention of Postmenopausal Osteoporosis.
What drug class is Dotti?
FDA lists estradiol in the Estrogen established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Dotti
- Is Dotti a controlled substance?Federal schedule
- What is Estradiol used for?FDA label uses
- Is Estradiol a controlled substance?Federal schedule
- Generic for AloraFDA Orange Book
- Generic for ClimaraFDA Orange Book
- Generic for FempatchFDA Orange Book
- Generic for MinivelleFDA Orange Book
- Generic for ElestrinFDA Orange Book
- Generic for EstroGelFDA Orange Book
- Generic for DivigelFDA Orange Book
- Generic for EstringFDA Orange Book
- Generic for ImvexxyFDA Orange Book
- Generic for EvamistFDA Orange Book
- Generic for EsclimFDA Orange Book
- Generic for EstradermFDA Orange Book
- Estrogens listFDA drug class