Ethinyldrug info
ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet
What it is used for
Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Prevention of Postmenopausal Osteoporosis
1.1 Treatment of
Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 6, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available: Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with "F51" on one side and "LU" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with "F52" on one side and "LU" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5-trien-20-yne-3,17-diol, (17α)-] Molecular Weight:
296.40 Molecular
Formula: C 20 H 24 O 2 Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-] Molecular Weight:
340.46 Molecular
Formula: C 22 H 28 O 3 Figure 1 Figure 2
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 6, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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