United States · FDA National Drug Code directory

TEMOZOLOMIDE

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
16571-816_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5
Product NDC
16571-816
Form
CAPSULE
Composition / generic term
temozolomide
Labeler
Rising Pharma Holdings, Inc.
Marketing category
ANDA
Marketing start / end (source format)
20221004
Source listing expiry
20261231

Source-listed ingredients

  • TEMOZOLOMIDE — 5 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 20 CAPSULE in 1 BOTTLE (16571-816-02) · 16571-816-02
  • 14 CAPSULE in 1 BOTTLE (16571-816-41) · 16571-816-41
  • 5 CAPSULE in 1 BOTTLE (16571-816-51) · 16571-816-51

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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