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 19 of 286 · 5,717 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared PlumETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559a9300-964e-ea9a-e063-6394a90a40162026-07-02WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt AirETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559a5f07-1557-c6d6-e063-6394a90a832f2026-07-02WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber GlowETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55242d92-04af-0224-e063-6394a90aee982026-07-02WarningsExact identifier
unii: 3K9958V90M
Family Beauty Hydrating Hand Sanitizer Watermelon ScentedALCOHOLFamily Dollar Stores, Inc.efe9989b-b729-439d-8489-3a100abcf8212026-07-02WarningsExact identifier
unii: 3K9958V90M
Family Beauty Hydrating Hand Sanitizer, Cucumber and Melon ScentedALCOHOLFamily Dollar Stores, Inc.dbd29c6e-fa01-49ad-a673-66b25f558ad42026-07-02WarningsExact identifier
unii: 3K9958V90M
Family Beauty Hydrating Hand Sanitizer, Coconut ScentedALCOHOLFamily Dollar Stores, Inc.35ce4c48-f260-4306-a886-add12820ac782026-07-02WarningsExact identifier
unii: 3K9958V90M
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Medi Fect Antiseptic Hand WashETHYL ALCOHOLMedical Chemical Corporationdc397d9c-9c12-41e5-ab7f-196fcad5bf972026-07-01WarningsExact identifier
unii: 3K9958V90M
AloeSafe Antiseptic Hand SanitizerETHYL ALCOHOLMedical Chemical Corporation950f012e-7908-523c-e053-2995a90afa6b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Berry BlissALCOHOLBath & Body Works, Inc.55935d41-ce7a-796a-e063-6294a90a6ba22026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Tangerine TwirlALCOHOLBath & Body Works, Inc.55933da8-dfbc-6877-e063-6394a90abb7f2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Watermelon WhirlALCOHOLBath & Body Works, Inc.559364cc-2b55-9628-e063-6394a90ac8e62026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach SandalwoodETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55984504-188f-13bc-e063-6394a90a91502026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ed5f-ed98-ebeb-e063-6294a90a2e8d2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry CremeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598c831-3986-00a5-e063-6394a90a1e662026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55982f73-7baa-26a7-e063-6394a90ab74b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55981d2a-d4de-af08-e063-6294a90a4b7c2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ff1f-b134-0beb-e063-6394a90a39a12026-07-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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