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 153 of 153 · 3,055 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.5c7d3287-883a-459b-9214-074a583c8a592019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: XF417D3PSL
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.461859ad-7833-47ae-90da-1dea5f26cc4b2018-12-01WarningsExact identifier
unii: 3K9958V90M
Foaming Mousse Anti-Bacterial Hand Sanitizer Pineapple ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f8139155-865c-40e5-a5c5-58a629361a0b2018-11-28WarningsExact identifier
unii: 3K9958V90M
Foaming Mousse Anti-Bacterial Hand Sanitizer Cherry ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.35bd0f8f-1602-4713-b20f-8dc38e2761c22018-11-28WarningsExact identifier
unii: 3K9958V90M
Afassco Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.efbcbfe1-27c6-45c9-b51e-926e298ee7532018-10-18WarningsExact identifier
unii: 3K9958V90M
Discount Drug Mart Vitamin E Hand SanitizerETHYL ALCOHOLDiscount Drug Mart8ce10d80-baab-4647-9abb-ebfd9009a1722018-02-09WarningsExact identifier
unii: 3K9958V90M
KidzStuff Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7ecf92e5-0ad6-41f0-bd02-2f79acb2b7222018-01-17WarningsExact identifier
unii: 3K9958V90M
Isopropyl AlcoholALCOHOLZee Medical8dc593e3-1163-4978-a39c-a9b29074699a2017-12-11WarningsExact identifier
unii: 3K9958V90M
Alcohol WipesALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.14dbe9dc-2504-4181-9565-5fa7c1a9c3772017-10-09WarningsExact identifier
unii: 3K9958V90M
Freeman Packaging Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.9827418a-3ab6-447b-8f8a-9eacb56d3a892017-10-09WarningsExact identifier
unii: 3K9958V90M
ONID WipeETHANOLONID Technology Corp83d8b8b6-6257-4553-9441-901bb02c3d602017-06-28Exact identifier
unii: 3K9958V90M
CVS Hand SanitizerALCOHOLCVSd0081c50-c0d2-436a-ba83-5d1982ae64b72015-08-17WarningsExact identifier
unii: 3K9958V90M
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: XF417D3PSL
Instant Hand SanitizerALCOHOLSafetec of America, Inc.f9e30645-491b-4f54-acfd-f863ee2356072013-08-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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