AMNEAL 801 Pill — WHITE;GREEN CAPSULE, 16mm — Temozolomide

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Imprint	AMNEAL / 801
Colour	WHITE;GREEN
Shape	CAPSULE
Size	16
Strength	TEMOZOLOMIDE 5 mg
Dosage form	Capsule
Manufacturer	Amneal Pharmaceuticals LLC
NDC	65162-801
Schedule	—
Availability	Prescription only
Ingredients	TEMOZOLOMIDE[TEMOZOLOMIDE]

What does this imprint mean?

The imprint "AMNEAL 801" 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

Temozolomide

Uses and warnings

BOXED WARNING: Myelosuppression - "Myelosuppression, including pancytopenia, leukopenia...and anemia, some with fatal outcomes, have occurred," with approximately 10% of patients requiring hospitalization or transfusion; blood counts must be monitored, with nadirs typically around day 26-28. Hepatotoxicity - "Fatal and severe hepatotoxicity have been reported" and liver function should be checked at baseline, mid-cycle, and after each cycle. Secondary malignancies, including myelodysplastic syndrome and secondary leukemias, have been observed. Contraindicated in patients with prior serious hypersensitivity to temozolomide or dacarbazine (shared metabolite). Also warns of Pneumocystis pneumonia risk, especially with concurrent steroid use, and embryo-fetal toxicity.

Indicated for adults with "newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment," and for "adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma" as well as "treatment of adults with refractory anaplastic astrocytoma."

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How to identify this pill

• Check the imprint matches exactly: "AMNEAL 801".
• Confirm the colour (WHITE;GREEN) and shape (CAPSULE).
• Compare the size (16) against a ruler if possible.
• When in doubt, confirm with a pharmacist before taking any medication.

AMNEAL 801 Pill — WHITE;GREEN CAPSULE, 16mm — Temozolomide

What does this imprint mean?

Active ingredient

Uses and warnings

How to identify this pill

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Official references