FDA.reportPublic FDA data

NDC 0527-1780 - 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
0527-1780
Package NDCs from labels
0527-1780-55, 0527-1780-14
Manufacturer
Lannett Company, Inc.
Effective date
2016-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temozolomide - Lannett Company, Inc.Lannett Company, Inc.2016-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1780-14Temozolomide14 in 1 BOTTLECAPSULE1413
0527-1780-55Temozolomide5 in 1 BOTTLECAPSULE513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1780TEMOZOLOMIDE CAPSULE [LANNETT COMPANY, INC.]132 package rows20160413_bd3eae4f-7294-4a42-b726-34193d6ba753.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 66 of 283 · 5,652 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsExact identifier
unii: 3K9958V90M
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsExact identifier
rxcui: 313210
rxcui: 313209
rxcui: 700885
rxcui: 313211
rxcui: 700883
rxcui: 317160
unii: YF1K15M17Y
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Advanced Hand SanitizerADVANCED HAND SANITIZERChain Drug Marketing Association49a1001c-8f4e-d0e7-e063-6394a90a53062026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLChain Drug Marketing Associationa85d93f2-e6f0-4fad-9ff7-6cbb62942bb22026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AdvancedETHYL ALCOHOLPerrigo Direct, Inc68eca241-acce-4f12-9643-bec9b14f53d02026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Advanced Hand SanitizerETHYL ALCOHOLMeijer, Inc.a56b4a66-3923-4e40-a461-1d97043fb89a2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Eucalyptus and SpearmintALCOHOLBath & Body Works, Inc.38d5ca92-2518-3dc4-e063-6394a90a2bc02026-02-19WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLMeijer, Inc.dd0bf473-b036-4a72-8caf-d9624d840fad2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLMeijer, Inc.6f6db114-c474-4b4b-971f-01743850cf3c2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer STRAWBERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe083f131-4b1c-42b5-947a-c4705d4fb00d2026-02-19WarningsExact identifier
unii: 3K9958V90M
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
PDI Alcohol Prep Pad Sterile Large and MediumALCOHOLProfessional Disposables International Inc8fe9cf1c-3f5f-4873-9648-6d4c79f8cf032026-02-18WarningsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Advanced Hand SanitizerETHYL ALCOHOLTarget Corporatione877e196-fa56-42e2-8b32-4509b1be85752026-02-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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