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 65 of 154 · 3,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
unii: B697894SGQ
Alcohol Gel Hand SanitizerALCOHOLEcolab Inc.6305da7a-f21c-4e94-a2c1-e1faac489df62025-12-30WarningsExact identifier
unii: 3K9958V90M
Protecting FHSALCOHOLEcolab50d1e501-c143-4446-84e7-7f3f278166af2025-12-30WarningsExact identifier
unii: 3K9958V90M
Facilipro Protecting FHSALCOHOLEcolabd6fccda4-f565-406b-aeb6-585b59bddf512025-12-30WarningsExact identifier
unii: 3K9958V90M
Retail Hand SanitizerALCOHOLEcolab Inc.55e65545-9869-413b-8239-bd2d43fe36d82025-12-30WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
unii: 3K9958V90M
Refreshify Antiseptic Hand WipesALCOHOLEmes Commerce Group Inc.46d2f10e-e1c2-3ca2-e063-6394a90a602d2025-12-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLAjenat Pharmaceuticals LLC636d6421-cadf-42b3-a431-ba40c06e36d22025-12-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PISTACHIO MATCHA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limiteddfd59d2e-9036-486a-b25b-7e5fe23421ce2025-12-26WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHANOLZep Inc.c72cf71f-e639-2854-e053-2a95a90ab30e2025-12-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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