FDA.reportPublic FDA data

temozolomide 5 MG Oral Capsule

RxCUI
313211
RxNorm name
temozolomide 5 MG Oral Capsule
Display name
temozolomide 5 MG Oral Capsule
Full name
temozolomide 5 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TemozolomideTEMOZOLOMIDEBryant Ranch Prepacka147b361-262c-49c6-9b8e-7e454f7557212026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 313211
TemozolomideTEMOZOLOMIDECivicaScript LLC56245d21-4a42-471e-bbdc-80b129336e2f2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 313211
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsExact identifier
rxcui: 313211
TemozolomideTEMOZOLOMIDESun Pharmaceutical Industries, Inc.c1e05c21-a411-4493-80de-ede3736324752025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 313211
TemozolomideTEMOZOLOMIDEAccord Healthcare Inc.2d599ccf-8e63-4ff1-aa52-4809744ea97a2025-05-23Warnings, Adverse reactionsExact identifier
rxcui: 313211
TemozolomideTEMOZOLOMIDEAscend Laboratories, LLC33d67bce-38ae-45fc-a858-d51167b0ecfd2025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 313211
TemozolomideTEMOZOLOMIDEDevatis, Inc.6b263fe0-5f06-4889-bf14-4aa1854708102024-11-30Warnings, Adverse reactionsExact identifier
rxcui: 313211
TEMOZOLOMIDETEMOZOLOMIDECamber Pharmaceuticals, Inc.78c12889-c837-40c1-8f85-4d048008ad292024-10-19Warnings, Adverse reactionsExact identifier
rxcui: 313211
TEMOZOLOMIDETEMOZOLOMIDERising Pharma Holdings, Inc.70996a9d-4a4f-4ed1-ab07-130486aa14ab2024-07-25Warnings, Adverse reactionsExact identifier
rxcui: 313211
TemozolomideTEMOZOLOMIDEAmneal Pharmaceuticals LLC6c8529ec-8936-4fec-a1a5-2b285c7e48592024-02-17Warnings, Adverse reactionsExact identifier
rxcui: 313211
temozolomideTEMOZOLOMIDENivagen Pharmaceuticals, Inc.27e5a781-e4f2-4489-9def-7971d0b86d9c2021-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313211

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 14 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
046a9011-3911-4d3f-a15f-fbb56d5aad56temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]240These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR ® (temozolomide) capsules, for oral use TEMODAR ® (temozolomide) for injection, for intravenous use Initial U.S. Approval: 199920260220
6c8529ec-8936-4fec-a1a5-2b285c7e4859temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]226These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 199920240217
c1e05c21-a411-4493-80de-ede373632475temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]224These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 199920251114
bd3eae4f-7294-4a42-b726-34193d6ba753temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]213These highlights do not include all the information needed to use temozolomide safely and effectively. See full prescribing information for temozolomide. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 199920160401
2d599ccf-8e63-4ff1-aa52-4809744ea97atemozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]210These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 199920250523
33d67bce-38ae-45fc-a858-d51167b0ecfdtemozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]29These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES, USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 199920250109
7d4fb55d-4837-0ea4-e053-2a91aa0afe70temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]28These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 199920240202
70996a9d-4a4f-4ed1-ab07-130486aa14abtemozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]26These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules for oral use Initial U.S. Approval: 199920240725
27e5a781-e4f2-4489-9def-7971d0b86d9ctemozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]25These highlights do not include all the information needed to use Temozolomide capsules, USP safely and effectively. See full prescribing information for Temozolomide capsules, USP. Temozolomide capsules, USP for oral use Initial U.S. Approval: 199920211128
56245d21-4a42-471e-bbdc-80b129336e2ftemozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]22These highlights do not include all the information needed to use TEMOZOLOMIDE Capsules for oral use safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 199920260428
bf47f075-67cd-4aa2-b56d-1b46bf3c3af5temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]21These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 199920260330
6b263fe0-5f06-4889-bf14-4aa185470810temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]21These highlights do not include all the information needed to use TEMOZOLOMIDE Capsules for oral use safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 199920241130
78c12889-c837-40c1-8f85-4d048008ad29temozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]21HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 199920241019
819571ea-b808-4fd8-93c7-1ea2e33d71cftemozolomide 5 MG Oral Capsule [PSN] · temozolomide 5 MG Oral Capsule [SCD]21These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) Capsules TEMODAR (temozolomide) for Injection administered via intravenous infusion Initial U.S. Approval: 199920110209