Ortho 535 Pill — WHITE ROUND, 6mm — Estradiol
| Imprint | Ortho / 535 |
|---|---|
| Colour | WHITE |
| Shape | ROUND |
| Size | 6 |
| Strength | norethindrone 0.5 mg;ethinyl estradiol 0.035 mg |
| Dosage form | Tablet |
| Manufacturer | Janssen Pharmaceuticals, Inc. |
| NDC | 50458-171 |
| Schedule | — |
| Availability | — |
| Ingredients | norethindrone[norethindrone];ethinyl estradiol[ethinyl estradiol] |
What does this imprint mean?
The imprint "Ortho 535" 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.
How to identify this pill
- • Check the imprint matches exactly: "Ortho 535".
- • Confirm the colour (WHITE) and shape (ROUND).
- • Compare the size (6) against a ruler if possible.
- • When in doubt, confirm with a pharmacist before taking any medication.
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Official references
Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file e4e5814f-9ca1-431c-bc30-ad18360f1535.xml