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 151 of 153 · 3,055 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 3K9958V90M
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
Liverex IGINKGO BILOBA, FEL TAURI, GALLBLADDER (SUIS), HEPAR SUIS), THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, MANGANUM METALLICUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ARSENICUM METALLICUM, SULPHUR, ACONITICUM ACIDUM, CIS, LYCOPODIUM CLAVATUM, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.1c23c489-0a43-4736-a30a-0ae02c09fb452023-07-21WarningsExact identifier
unii: XF417D3PSL
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: XF417D3PSL
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
unii: 3K9958V90M
LY-COANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.47140966-5b49-432d-bf35-bcae14f420822023-06-01WarningsExact identifier
unii: XF417D3PSL
Lyme and Co-Infection NosodeANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.f6186157-256f-4454-b122-f7665e3286f42023-06-01WarningsExact identifier
unii: XF417D3PSL
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
CitriPlusJUGLANS REGIA WHOLE AND ANHYDROUS CITRIC ACIDPEKANA Natuheilmittel GmbH11db1b5b-2959-42c4-a059-25c9519330042023-01-11WarningsExact identifier
unii: XF417D3PSL
Zylast Antiseptic SETHYL ALCOHOLInnovative BioDefense86857d95-56b4-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
unii: 3K9958V90M
Antiseptic WipesZYLAST HAND WIPESWestwood Laboratoriesaf269e6c-3cfb-b6f6-e053-2a95a90a44242023-01-01WarningsExact identifier
unii: 3K9958V90M
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), PHLORIDZINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, BARYTA OXALICA, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS,Deseret Biologicals, Inc.5117f980-95b8-4fc8-9425-8f6f056394372022-12-29WarningsExact identifier
unii: XF417D3PSL
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
SpectricETHYLICUM, KALI BROMATUM, ASPARTIC ACID, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGENDeseret Biologicals, Inc3e534017-4a9f-42a2-bdfd-1e8c73c0515a2022-11-08WarningsExact identifier
unii: 3K9958V90M
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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