FDA.reportPublic FDA data

NDC 70301-2005-01 - 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
70301-2005
Requested NDC
70301-2005-01
Package NDCs from labels
70301-2005-1, 70301-2005-2, 70301-2005-01
Manufacturer
OPKO Pharmaceuticals, LLC
Effective date
2026-09-29
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, LLC2026-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70301-2005-1Temozolomide1 in 1 PACKETCAPSULE12
70301-2005-1Temozolomide5 in 1 CARTONCAPSULE52
70301-2005-2Temozolomide1 in 1 PACKETCAPSULE12
70301-2005-2Temozolomide14 in 1 CARTONCAPSULE142

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 54 of 315 · 6,288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLWinCo Foods, LLCc22a5fc3-78f5-4660-96a6-479ca6f776022026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLWinCo Foods, LLC2b48ee19-8f0c-4b36-855d-7909dde5c8712026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Ethyl Rubbing AlcoholETHYL ALCOHOLAmazon.com Services LLC5369424a-ccbd-4dc6-af6b-7876484a9fe62026-04-06Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Surface Hand Sanitizer Caramel LatteETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.4ec35a8b-d82a-2c0f-e063-6394a90a4d502026-04-05WarningsExact identifier
unii: 3K9958V90M
Surface Hand Sanitizer Cherry PieETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.4ec37212-c015-6f7c-e063-6394a90af70a2026-04-05WarningsExact identifier
unii: 3K9958V90M
Surface Hand Sanitizer SurpriseETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.4ec389af-d85a-98f5-e063-6394a90a99512026-04-05WarningsExact identifier
unii: 3K9958V90M
Caring Mill Triple Hand Sanitizer with LavenderETHYL ALCOHOLFSA Store Inc. (Caring Mills)4b0b5436-a1ce-cfa6-e063-6394a90a2efe2026-04-04WarningsExact identifier
unii: 3K9958V90M
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Hand Sanitizer Passion ParadiseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e850ea9-0999-12b4-e063-6394a90af4062026-04-02WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Tropical MangoALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85630a-6d18-e6a4-e063-6394a90a1d122026-04-02WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Coco CabanaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85923b-6b8c-f9a2-e063-6294a90a0d8e2026-04-02WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Sea BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85e279-7751-8bd7-e063-6294a90a095b2026-04-02WarningsExact identifier
unii: 3K9958V90M
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4
Medt PadISOPROPYL ALCOHOLCarelife (USA) Inc.74a05c37-becd-4c93-96cb-79f69add5e4d2026-04-02WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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