FDA.reportPublic FDA data

temozolomide 20 MG Oral Capsule

RxCUI
313209
RxNorm name
temozolomide 20 MG Oral Capsule
Display name
temozolomide 20 MG Oral Capsule
Full name
temozolomide 20 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 Prepackc0f2077c-48e6-452e-9f88-e1f2c89df0a22026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 313209
TemozolomideTEMOZOLOMIDECivicaScript LLC56245d21-4a42-471e-bbdc-80b129336e2f2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 313209
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsExact identifier
rxcui: 313209
TemozolomideTEMOZOLOMIDESun Pharmaceutical Industries, Inc.c1e05c21-a411-4493-80de-ede3736324752025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 313209
TemozolomideTEMOZOLOMIDEAccord Healthcare Inc.2d599ccf-8e63-4ff1-aa52-4809744ea97a2025-05-23Warnings, Adverse reactionsExact identifier
rxcui: 313209
TemozolomideTEMOZOLOMIDEAscend Laboratories, LLC33d67bce-38ae-45fc-a858-d51167b0ecfd2025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 313209
TemozolomideTEMOZOLOMIDEDevatis, Inc.6b263fe0-5f06-4889-bf14-4aa1854708102024-11-30Warnings, Adverse reactionsExact identifier
rxcui: 313209
TEMOZOLOMIDETEMOZOLOMIDECamber Pharmaceuticals, Inc.78c12889-c837-40c1-8f85-4d048008ad292024-10-19Warnings, Adverse reactionsExact identifier
rxcui: 313209
TEMOZOLOMIDETEMOZOLOMIDERising Pharma Holdings, Inc.70996a9d-4a4f-4ed1-ab07-130486aa14ab2024-07-25Warnings, Adverse reactionsExact identifier
rxcui: 313209
TemozolomideTEMOZOLOMIDEAmneal Pharmaceuticals LLC6c8529ec-8936-4fec-a1a5-2b285c7e48592024-02-17Warnings, Adverse reactionsExact identifier
rxcui: 313209
temozolomideTEMOZOLOMIDENivagen Pharmaceuticals, Inc.27e5a781-e4f2-4489-9def-7971d0b86d9c2021-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313209

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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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
28fae355-e29a-4f76-9c83-bc44663ff7d4temozolomide 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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 20 MG Oral Capsule [PSN] · temozolomide 20 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