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 28 of 154 · 3,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Beaded Wristlet Lily WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a8084-a67b-77da-e063-6394a90a4ff92026-05-19WarningsExact identifier
unii: 3K9958V90M
Berry Bougie Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC51d843af-dad3-75fd-e063-6394a90a6b572026-05-18WarningsExact identifier
unii: 3K9958V90M
Meijer Hand Sanitizer Fall Harvest AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.5213f632-33a0-aa45-e063-6294a90a71a02026-05-18WarningsExact identifier
unii: 3K9958V90M
Meijer Hand Sanitizer Fall Harvest Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.522413eb-d7e3-65ea-e063-6394a90a942b2026-05-18WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Beaded Wristlet RosewateALCOHOLShenzhen Lantern Scicence Co.,Ltd.52245438-751b-b52e-e063-6394a90aeb472026-05-18WarningsExact identifier
unii: 3K9958V90M
KOOL AID HAND SANITIZER TROPICAL PUNCHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27d8-81a3-e063-6294a90afc802026-05-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.520e7b2b-e24e-5ce7-e063-6294a90a986d2026-05-17WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Rosewater and LotusALCOHOLGOJO Industries, LLC51db0a20-3606-b52d-e063-6294a90a259d2026-05-15WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Chamomile and LemongrassALCOHOLGOJO Industries, LLC51dc63f4-d775-6b99-e063-6294a90a88cb2026-05-15WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Eucalyptus and Tea TreeALCOHOLGOJO Industries, LLC51dc704b-ce36-952b-e063-6294a90ad20e2026-05-15WarningsExact identifier
unii: 3K9958V90M
Hand SanALCOHOLRochester Midland Corporation2d89982d-d1fd-4a98-8b44-c2ae3545be582026-05-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ae8f8d-8969-9605-e063-6394a90a42252026-05-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.51af80be-dcc8-f5c3-e063-6394a90a32542026-05-13WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Caramel LatteALCOHOLI WORLD, LLCbdab8c55-1624-49c5-8357-27f68b86f7c72026-05-13WarningsExact identifier
unii: 3K9958V90M
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
unii: B697894SGQ
Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios Inc.80e475a5-97d7-4ad9-9be1-0ccdb42e6fce2026-05-12WarningsExact identifier
unii: 3K9958V90M
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.408ba9aa-6e03-48fe-a08e-799dbaa3408c2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care ROSEWATER HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0a5a21d9-6832-47a2-a4bb-83781aaa61aa2026-05-12WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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