FDA.reportPublic FDA data

Temozolomide

Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2021-02-24
Label type
BULK INGREDIENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:49:54

Label at a glance#

ProductTemozolomide
Active ingredientTEMOZOLOMIDE
Label structure1 sections

Label contents#

Full prescribing information#

Temozolomide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3afbbf09-a1e0-475e-b654-466d26d19d69Product name920170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73309-031-01Temozolomide100 g in 1 JARPOWDER1003
73309-031-02Temozolomide50 g in 1 JARPOWDER503
73309-031-03Temozolomide25 g in 1 JARPOWDER253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-031TEMOZOLOMIDE POWDER [BLUEBAY SHANDONG CO.,LTD]33 package rows20210225_f27d4938-3ddf-4349-a2bb-d4fd7e6cfda4.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73309-03173309-031-01, 73309-031-02, 73309-031-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLC9dff10ec-6a55-47b6-a458-b7c39e32dc552026-08-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCf6d762ea-fff0-43e8-b67d-bef19e883dd82026-08-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCf743f7e0-74cf-47e5-bf21-f2b75d2596dc2026-08-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCb3f69c67-db30-4266-8075-9b18c71c9fc12026-08-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
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.