FDA.reportPublic FDA data

NDC 68083-201 - 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
68083-201
Package NDCs from labels
68083-201-01
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-201TEMSIROLIMUS (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 90 of 154 · 3,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aab23c1-53ad-9e60-e063-6394a90a26ec2025-07-24WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aabb047-7277-d9cb-e063-6394a90a92242025-07-24WarningsExact identifier
unii: 3K9958V90M
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.7088fa66-a972-4439-aef3-633808b5eafb2025-07-22WarningsExact identifier
unii: 3K9958V90M
BiopureHAND SANITIZER SPRAYQuest USA Corp3249f563-7968-e512-e063-6394a90aad522025-07-18WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1c90df-19ee-b249-e063-6394a90af33b2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1cd4ae-4a6e-bfcc-e063-6394a90aad032025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1d0f0b-e330-f674-e063-6394a90aec492025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLMY IMPORTS USA LLC3a2a1165-b710-3bf6-e063-6294a90a352d2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLMY IMPORTS USA LLC3a2a36bb-c55d-67a0-e063-6294a90a1cf42025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLMY IMPORTS USA LLC3a2a4539-30eb-7451-e063-6294a90a2c222025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLMY IMPORTS USA LLC3a2a4fab-6776-7359-e063-6294a90a85242025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a186822-025c-6970-e063-6394a90a5dc12025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care WILD ROSE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e98e8f32-94f9-45b6-94b3-93c62a8a3f172025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care CALMING LAVENDER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.38a7d367-7a33-48dc-84e7-fce894bf79fa2025-07-16WarningsExact identifier
unii: 3K9958V90M
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: XF417D3PSL
Smart Care FRESH RAIN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.dfdd5255-9033-4a22-a03c-922c3a33d24d2025-07-15WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS Lovely Lavender Scent HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.73695c5e-664c-466f-9d84-ae4b115da23f2025-07-15WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholDEHYDRATED ALCOHOLIngenus Pharmaceuticals, LLC1d5ec6f9-d58f-4651-a4a1-93fec13fd4382025-07-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: XF417D3PSL
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a417a8-afec-f893-e063-6394a90a70ae2025-07-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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