54108 Pill — WHITE;WHITE CAPSULE, 18mm — Temozolomide
| Imprint | 54108 |
|---|---|
| Colour | WHITE;WHITE |
| Shape | CAPSULE |
| Size | 18 |
| Strength | TEMOZOLOMIDE 250 mg |
| Dosage form | Capsule |
| Manufacturer | Roxane Laboratories, Inc |
| NDC | 0054-0325 |
| Schedule | — |
| Availability | — |
| Ingredients | TEMOZOLOMIDE[TEMOZOLOMIDE] |
What does this imprint mean?
The imprint "54108" 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."
How to identify this pill
- • Check the imprint matches exactly: "54108".
- • Confirm the colour (WHITE;WHITE) and shape (CAPSULE).
- • Compare the size (18) 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 910d587e-5e7b-4a49-ae91-e802baf4bff0.xml