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 68 of 283 · 5,652 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlcoholALCOHOLUlinefdda41fa-d847-4cee-a070-91f0600b0fc82026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel The Upside DownALCOHOLBath & Body Works, Inc.29a539bb-42e7-dc73-e063-6394a90a5fe92026-02-17WarningsExact identifier
unii: 3K9958V90M
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.38d661c8-6f48-f58c-e063-6294a90ae8c12026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.38951f0d-0ec4-2406-e063-6394a90a9fe32026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38d656e3-5f8f-9874-e063-6394a90a8ea52026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus MintALCOHOLBath & Body Works, Inc.38d65eae-f1af-f342-e063-6294a90af7fe2026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer OCEAN BREEZE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2cf4bc63-6157-4c4f-bb52-aa685f8d4aee2026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO15a5272c-0abc-47e1-be21-91a601ead3082026-02-17WarningsExact identifier
unii: 3K9958V90M
AURA LANE HAND SANITIZER Neroli Flower ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO1cd1c0ee-1849-4003-a128-323d1b06aa402026-02-17WarningsExact identifier
unii: 3K9958V90M
hand sanitizer chocolate chip pancake scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO105d2927-59e1-46fb-ad48-ea45ed3051e82026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer MANDARIN ORANGE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO20a8d48d-aa4b-4904-84e9-54be5ddb43a02026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9eece9a7-3340-47ea-98aa-152d285e4c012026-02-16WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SWEET CHERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO990a5e7b-8fe4-4681-99eb-76445f9436a72026-02-16WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLC490a3484-04d7-4a90-b203-71971a869e8d2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLCe1bd99f5-8a96-442a-8c70-367df96c5cf02026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLVeritiv Operating Company3b8a41b3-54c5-f5c0-e063-6394a90a9fac2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLValu Merchandisers Company722abec8-5a05-4e6d-a7ea-da9d1009e8592026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLValu Merchandisers Companye8b82c44-cbe0-42b2-b920-fed8da8f79eb2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer CARAMEL DREAM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO65702a16-5a66-412a-b288-4d64488c1c422026-02-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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