FDA.reportPublic FDA data

NDC 73309-031-03 - Temozolomide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73309-031
Requested NDC
73309-031-03
Package NDCs from labels
73309-031-01, 73309-031-02, 73309-031-03
Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2021-02-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temozolomide - BLUEBAY SHANDONG CO.,LTDBLUEBAY SHANDONG CO.,LTD2021-02-24BULK INGREDIENT

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

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 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLC9dff10ec-6a55-47b6-a458-b7c39e32dc552026-08-27Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCf6d762ea-fff0-43e8-b67d-bef19e883dd82026-08-27Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCf743f7e0-74cf-47e5-bf21-f2b75d2596dc2026-08-27Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCb3f69c67-db30-4266-8075-9b18c71c9fc12026-08-27Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDECivicaScript LLC56245d21-4a42-471e-bbdc-80b129336e2f2026-08-11Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack79766855-2533-43b1-b60e-1e9daecadad52026-06-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack021b97cc-a76f-44b6-b7be-670d2ae836902026-06-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEBryant Ranch Prepackc0f2077c-48e6-452e-9f88-e1f2c89df0a22026-06-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack38f17780-8037-44a0-9e84-b7150c9bde122026-06-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack6eb0bd33-582f-43a6-a607-e72b4390c6d32026-06-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEBryant Ranch Prepacka147b361-262c-49c6-9b8e-7e454f7557212026-06-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDESun Pharmaceutical Industries, Inc.c1e05c21-a411-4493-80de-ede3736324752025-11-14Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEAccord Healthcare Inc.2d599ccf-8e63-4ff1-aa52-4809744ea97a2025-05-23Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEAscend Laboratories, LLC33d67bce-38ae-45fc-a858-d51167b0ecfd2025-01-09Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEDevatis, Inc.6b263fe0-5f06-4889-bf14-4aa1854708102024-11-30Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TEMOZOLOMIDETEMOZOLOMIDECamber Pharmaceuticals, Inc.78c12889-c837-40c1-8f85-4d048008ad292024-10-19Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TEMOZOLOMIDETEMOZOLOMIDERising Pharma Holdings, Inc.70996a9d-4a4f-4ed1-ab07-130486aa14ab2024-07-25Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
TemozolomideTEMOZOLOMIDEAmneal Pharmaceuticals LLC6c8529ec-8936-4fec-a1a5-2b285c7e48592024-02-17Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y
temozolomideTEMOZOLOMIDENivagen Pharmaceuticals, Inc.27e5a781-e4f2-4489-9def-7971d0b86d9c2021-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YF1K15M17Y

Reported adverse events (FAERS/openFDA)#

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