FDA.reportPublic FDA data

TEMOZOLOMIDE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2017-07-06
Label type
Indexing - product concept
Version
9
Source
full-release
Hydrated at
2026-06-05 00:17:04

Label at a glance#

ProductTEMOZOLOMIDE
Active ingredientTEMOZOLOMIDE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEMOZOLOMIDEYF1K15M17YACTIB
TEMOZOLOMIDEYF1K15M17YACTIB
TEMOZOLOMIDEYF1K15M17YACTIB
TEMOZOLOMIDEYF1K15M17YACTIB
TEMOZOLOMIDEYF1K15M17YACTIB
TEMOZOLOMIDEYF1K15M17YACTIB
TEMOZOLOMIDEYF1K15M17YACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TemozolomideTEMOZOLOMIDECivicaScript LLC56245d21-4a42-471e-bbdc-80b129336e2f2026-08-11Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack79766855-2533-43b1-b60e-1e9daecadad52026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack021b97cc-a76f-44b6-b7be-670d2ae836902026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepackc0f2077c-48e6-452e-9f88-e1f2c89df0a22026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack38f17780-8037-44a0-9e84-b7150c9bde122026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack6eb0bd33-582f-43a6-a607-e72b4390c6d32026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepacka147b361-262c-49c6-9b8e-7e454f7557212026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsName fallback
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDESun Pharmaceutical Industries, Inc.c1e05c21-a411-4493-80de-ede3736324752025-11-14Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEAccord Healthcare Inc.2d599ccf-8e63-4ff1-aa52-4809744ea97a2025-05-23Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEAscend Laboratories, LLC33d67bce-38ae-45fc-a858-d51167b0ecfd2025-01-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEDevatis, Inc.6b263fe0-5f06-4889-bf14-4aa1854708102024-11-30Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TEMOZOLOMIDETEMOZOLOMIDECamber Pharmaceuticals, Inc.78c12889-c837-40c1-8f85-4d048008ad292024-10-19Warnings, Adverse reactionsName fallback
brand name: TEMOZOLOMIDE
generic name: TEMOZOLOMIDE
TEMOZOLOMIDETEMOZOLOMIDERising Pharma Holdings, Inc.70996a9d-4a4f-4ed1-ab07-130486aa14ab2024-07-25Warnings, Adverse reactionsName fallback
brand name: TEMOZOLOMIDE
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEAmneal Pharmaceuticals LLC6c8529ec-8936-4fec-a1a5-2b285c7e48592024-02-17Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
temozolomideTEMOZOLOMIDENivagen Pharmaceuticals, Inc.27e5a781-e4f2-4489-9def-7971d0b86d9c2021-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temozolomide
generic name: TEMOZOLOMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.