FDA.reportPublic FDA data

NDC 70301-2003 - 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
70301-2003
Package NDCs from labels
70301-2003-1, 70301-2003-2
Manufacturer
OPKO Pharmaceuticals, LLC
Effective date
2026-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temozolomide - OPKO Pharmaceuticals, LLCOPKO Pharmaceuticals, LLC2026-03-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70301-2003-1Temozolomide1 in 1 PACKETCAPSULE11
70301-2003-1Temozolomide5 in 1 CARTONCAPSULE51
70301-2003-2Temozolomide14 in 1 CARTONCAPSULE141
70301-2003-2Temozolomide1 in 1 PACKETCAPSULE11

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 157 of 318 · 6,355 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 15FIX9V2JP
Smart Care TANGY TERRANE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.07e3e67a-827a-4143-8d13-ec6b8dad49972025-10-31WarningsExact identifier
unii: 3K9958V90M
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
unii: 15FIX9V2JP
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
unii: ND2M416302
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
Surface x Cutie Pals Hand Sanitizer Citrus CrushALCOHOLLongway Technology(Guangzhou)Co., Ltd.675ab652-d867-4613-8d3a-f0631da9b8622025-10-30WarningsExact identifier
unii: 3K9958V90M
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Surface x Cutie Pals Hand Sanitizer Coconut MilkALCOHOLLongway Technology(Guangzhou)Co., Ltd.e0a473b6-0d56-4566-b533-17dfb9c51ab62025-10-30WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLLongway Technology(Guangzhou)Co., Ltd.ead7cefb-49b5-4405-a2bc-333f11280a0e2025-10-30WarningsExact identifier
unii: 3K9958V90M
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
unii: 15FIX9V2JP
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
unii: 3K9958V90M
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Symmetry Hand SanitizerALCOHOLBuckeye International, Inc.7f38c146-b5d3-489e-b1c7-89dcea2c18a82025-10-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
unii: 15FIX9V2JP
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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