NDC 68083-200 - Temsirolimus

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
68083-200
Package NDCs from labels
68083-200-01
Manufacturer
Gland Pharma Limited
Effective date
2022-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temsirolimus Injection - Gland Pharma LimitedGland Pharma Limited2022-10-07Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-200-01Temsirolimus1.0 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE1.0 mL25 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-200TEMSIROLIMUS (TEMSIROLIMUS INJECTION) KIT [GLAND PHARMA LIMITED]6Unmatched20221008_d7ee3165-175d-4439-8740-fbfed18aaf0e.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 139 of 153 · 3,055 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Algonquin HanSanALCOHOLWhisk Products, Inc.1808f5ab-4bee-4768-995b-911b10cfa18b2023-12-08WarningsExact identifier
unii: 3K9958V90M
D-GermALCOHOLWhisk Products, Inc.fe08fb0c-007c-40a7-e053-6294a90acac92023-12-08WarningsExact identifier
unii: 3K9958V90M
Pacific Breeze Instant Hand Sanitizer GelALCOHOLWhisk Products, Inc.3f574300-b05a-4f98-98fa-dd2177bb3d752023-12-08WarningsExact identifier
unii: 3K9958V90M
Pretty Pump Hand SanitizerALCOHOLWhisk Products, Inc.c6d6ca9a-9fe7-4a6d-8179-e085a4b414c82023-12-08WarningsExact identifier
unii: 3K9958V90M
AP HanSanALCOHOLWhiskProducts, Inc.e212fd90-f4e4-44c4-bfb7-16e313c30be92023-12-07WarningsExact identifier
unii: 3K9958V90M
Aire-Master Waterless Hand SanitizerALCOHOLWhisk Products, Inc.8f0b77b1-ef16-4a3c-874b-07f78d6a45b72023-12-07WarningsExact identifier
unii: 3K9958V90M
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
unii: 3K9958V90M
ALCOHOL ANTISEPTIC HAND SANITIZERALCOHOLCustom Quest, Inc.70dd10e3-1958-43a6-af7e-29ca900b00f62023-12-04WarningsExact identifier
unii: 3K9958V90M
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDb57c7e3a-f0bf-fd42-e053-2a95a90a3b4f2023-12-01WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLASC Marketing LTDb57c8ae8-dfb1-a959-e053-2995a90abddf2023-12-01WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56d6034-cac2-a9e2-e053-2a95a90aebf02023-12-01WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56dc975-af3c-fdbe-e053-2a95a90a647b2023-12-01WarningsExact identifier
unii: 3K9958V90M
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDbf0098ab-6c0d-ecd2-e053-2a95a90a670c2023-12-01WarningsExact identifier
unii: 3K9958V90M
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
unii: 3K9958V90M
B-Pure Citrus scented Hand SanitizingALCOHOLFourstar Group USA, Inc.809f18fa-46ad-4366-bb76-96ab0e787ded2023-11-30WarningsExact identifier
unii: 3K9958V90M
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.5ca7c520-d099-4900-9e37-7f624397e5782023-11-30WarningsExact identifier
unii: 3K9958V90M
B-Pure Citrus Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.0a22230e-d511-041d-e063-6394a90aade92023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef706620b-15b3-4468-e053-6394a90a83172023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef7070892-741f-e528-e053-6294a90aee7a2023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef707644e-aa2c-d80a-e053-6394a90a33312023-11-30WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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