HRT · Bioidentical hormones
The complete list of FDA-approved bioidentical hormones (2026).
Bioidentical hormones do not have to be compounded. Every hormone in this list is FDA-approved, mass-manufactured, purity-tested, and available at most U.S. pharmacies. Here is the definitive 2026 list.
FDA-approved bioidentical estradiol (patch)
- Climara — once-weekly matrix patch. 0.025, 0.0375, 0.05, 0.06, 0.075, 0.1 mg/day.
- Vivelle-Dot — twice-weekly matrix patch. 0.025, 0.0375, 0.05, 0.075, 0.1 mg/day.
- Minivelle — smallest twice-weekly patch on market.
- Alora — twice-weekly matrix patch.
- Estraderm — reservoir patch (older format, still available).
- Generic estradiol transdermal patch — twice-weekly and weekly options.
FDA-approved bioidentical estradiol (oral)
- Estrace tablets — 0.5, 1, 2 mg.
- Generic estradiol tablets — same strengths.
FDA-approved bioidentical estradiol (topical)
- Divigel — daily gel packet (0.25, 0.5, 0.75, 1.0, 1.25 mg).
- EstroGel — daily pump gel (0.75 mg per pump).
- Elestrin — daily metered-dose gel.
- Evamist — transdermal spray to inner forearm.
FDA-approved bioidentical estradiol (vaginal)
- Estrace cream and generic estradiol vaginal cream.
- Vagifem / Yuvafem — 10 mcg estradiol tablets.
- Imvexxy — 4 or 10 mcg soft-gel insert (generic available).
- Estring — 3-month sustained-release vaginal ring.
FDA-approved bioidentical progesterone
- Prometrium — oral micronized progesterone. 100 or 200 mg at bedtime.
- Generic micronized progesterone — same strengths.
- Crinone / Endometrin — vaginal micronized progesterone (mostly used in fertility, but FDA-approved bioidentical).
FDA-approved bioidentical combined products
- CombiPatch — estradiol + norethindrone acetate (patch).
- Climara Pro — estradiol + levonorgestrel (patch).
- Activella — estradiol + norethindrone acetate (pill).
- Bijuva — estradiol + micronized progesterone (fully bioidentical combined pill).
Testosterone (limited FDA-approved options for women)
The FDA has not approved a testosterone product specifically for women in the U.S. Testosterone use in women is off-label, typically prescribed as a low-dose compounded cream. The Global Consensus Position Statement (2019) supports its use for postmenopausal hypoactive sexual desire disorder.
FDA-approved vs compounded bioidentical: what to know
NAMS 2022 and the Endocrine Society both recommend FDA-approved bioidentical hormones first. Compounded bioidentical hormone therapy is reserved for patients who cannot use commercial preparations (allergy, dose gap, unavailable form). A Kindr clinician will always try to match you to an FDA-approved bioidentical product first.
Frequently asked questions
What are FDA-approved bioidentical hormones?
FDA-approved bioidentical hormones are estradiol, estriol (limited), progesterone (micronized), and testosterone products manufactured by regulated pharmaceutical companies and reviewed by the FDA for identity, purity, potency, and clinical efficacy. They are chemically identical to the hormones your ovaries make. This is distinct from "compounded bioidentical hormones," which are custom-mixed at pharmacies and are not individually FDA-approved.
Is Prometrium a bioidentical hormone?
Yes. Prometrium is FDA-approved oral micronized progesterone — chemically identical to the progesterone your ovaries produce. It is one of the most widely prescribed bioidentical hormones in menopause care.
Is estradiol a bioidentical hormone?
Yes. 17β-estradiol is the exact estrogen your ovaries produce. FDA-approved estradiol comes in patches (Climara, Vivelle-Dot, Minivelle, generic), pills (Estrace, generic), gels (Divigel, EstroGel, Elestrin), sprays (Evamist), and vaginal preparations (Estrace cream, Vagifem, Imvexxy, Estring).
Is Premarin bioidentical?
No. Premarin is conjugated equine estrogens — a mixture of estrogens derived from pregnant mare urine. It is FDA-approved and effective, but not chemically identical to human estrogen, so it is not bioidentical.
Are compounded bioidentical hormones FDA-approved?
No. Compounded bioidentical hormone therapy (cBHT) is custom-mixed at compounding pharmacies. Individual formulations are not FDA-reviewed for identity, purity, or dosing accuracy. NAMS 2022 and the Endocrine Society recommend FDA-approved bioidentical products first, reserving compounding for patients who cannot use commercial preparations.
Can I get FDA-approved bioidentical hormones online?
Yes. Kindr prescribes FDA-approved bioidentical estradiol (patch, gel, spray, pill, vaginal) and micronized progesterone. A board-certified clinician licensed in your state reviews your intake and, if appropriate, prescribes and ships from a licensed U.S. pharmacy. Available in all 50 states.
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Medically reviewed by Kindr Health Clinical Team · Last reviewed 2026-06-19. Compounded medications are prepared by FDA-registered 503A pharmacies and are not FDA-approved drug products.