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 152 of 153 · 3,055 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
TemsirolimusTEMSIROLIMUS INJECTIONGland Pharma Limitedd7ee3165-175d-4439-8740-fbfed18aaf0e2022-10-07Warnings, Adverse reactionsExact identifier
application number: ANDA207383
ndc (package): 68083-201-01
ndc (package): 68083-202-01
ndc (package): 68083-200-01
ndc (product): 68083-202
rxcui: 722289
spl id: 6dd61a73-2d62-4f94-9617-643d8b896fde
spl set id: d7ee3165-175d-4439-8740-fbfed18aaf0e
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: XF417D3PSL
TemsirolimusTEMSIROLIMUSFresenius Kabi USA, LLC1c207bed-10e3-46f0-ad2c-69d5e5c977362020-03-30Warnings, Adverse reactionsExact identifier
application number: ANDA207383
rxcui: 722289
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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