FDA.reportPublic FDA data

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 36 of 154 · 3,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4e432300-7d2f-ed59-e063-6394a90a22b82026-03-30WarningsExact identifier
unii: 3K9958V90M
IsagelALCOHOLColoplast Corpeba7e574-25c2-445a-98f6-2d10454554662026-03-27WarningsExact identifier
unii: 3K9958V90M
Giant EagleALCOHOLApollo Health and Beauty Care419846a1-8d22-16f0-e063-6394a90a6bdd2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance FreeALCOHOLGOJO Industries, Inc.4e06bb4a-e1a5-8c79-e063-6294a90a293c2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer be BlissfulALCOHOLGOJO Industries, Inc.cebd0adb-dc26-407f-a290-418e0e206aea2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Fig ScentedALCOHOLFourstar Group USA, Inc.b66cd8a7-98ea-43b0-a92b-7d1da15f50142026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Cherry ScentedALCOHOLFourstar Group USA, Inc.290674c5-1622-451e-abd6-b586117827c32026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Vanilla Honey ScentedALCOHOLFourstar Group USA, Inc.f2eb0f80-083e-478a-a8df-0d2bb85901ad2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Peachy Cherry Bliss ScentedALCOHOLFourstar Group USA, Inc.835a6a4c-1582-46fd-b5c3-4b79dbe11d502026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand SanitizerSugared Strawberry ScentedALCOHOLFourstar Group USA, Inc.15e732fe-5c4b-4f3a-9dd5-a4f7015f75422026-03-27WarningsExact identifier
unii: 3K9958V90M
IsagelALCOHOLColoplast Corp5be93a24-c644-4e6b-a600-87f0a5a09e5c2026-03-27WarningsExact identifier
unii: 3K9958V90M
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: B697894SGQ
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Palm Island Breeze ScentedALCOHOLFourstar Group USA, Inc.afe2d7d6-7ce8-4115-b175-6ab39402eb792026-03-25WarningsExact identifier
unii: 3K9958V90M
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsExact identifier
unii: 3K9958V90M
palm partyALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.48786094-aa70-d0ca-e063-6394a90acd882026-03-25WarningsExact identifier
unii: 3K9958V90M
palm partyALCOHOL GELDongyang Loulee Cosmetics Co.,Ltd.487c4724-b618-a071-e063-6394a90aa7822026-03-25WarningsExact identifier
unii: 3K9958V90M
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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