M53 LU Pill — WHITE ROUND, 6mm — Estradiol

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Imprint	M53 / LU
Colour	WHITE
Shape	ROUND
Size	6
Strength	ESTRADIOL 0.5 mg;NORETHINDRONE 0.1 mg
Dosage form	Tablet
Manufacturer	Lupin Pharmaceuticals, Inc.
NDC	68180-829
Schedule	—
Availability	—
Ingredients	ESTRADIOL[ESTRADIOL];NORETHINDRONE[NORETHINDRONE]

What does this imprint mean?

The imprint "M53 LU" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Estradiol

Uses and warnings

BOXED WARNING: "ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER" in women with a uterus, with risk related to dose and duration of use; "close clinical surveillance of all women taking estrogens is important." The label also states "estrogens with or without progestins should not be used for the prevention of cardiovascular disease," citing Women's Health Initiative findings of "increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis" and an increased risk of dementia in women 65 and older. Contraindications include undiagnosed abnormal genital bleeding, known or suspected breast cancer, active or history of DVT/PE or arterial thromboembolic disease, liver dysfunction, known or suspected pregnancy, and known hypersensitivity.

Indicated for treatment of moderate to severe vasomotor symptoms (hot flashes) and moderate to severe vulvar and vaginal atrophy associated with menopause; treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; palliative treatment of certain cases of metastatic breast cancer and advanced androgen-dependent prostate cancer; and prevention of postmenopausal osteoporosis.

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