FDA.reportPublic FDA data

NDC 68083-133-01 - ketorolac tromethamine

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
68083-133
Requested NDC
68083-133-01
Package NDCs from labels
68083-133-01, 68083-133-10
Manufacturer
Gland Pharma Limited
Effective date
2024-09-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ketorolac tromethamine - Gland Pharma LimitedGland Pharma Limited2024-09-20Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-133-01ketorolac tromethamine1 mL in 1 VIALINJECTION, SOLUTION115
68083-133-10ketorolac tromethamine10 in 1 CARTONINJECTION, SOLUTION1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-133KETOROLAC TROMETHAMINE INJECTION, SOLUTION [GLAND PHARMA LIMITED]15Current NDC, Legacy NDC, 2 package rows20240921_5abd4389-4fb2-408b-a27e-cf64b6a921f1.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 188 · 3,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care PASSION PARADISE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.f6819964-c426-427b-bdff-40cfb1a758c42026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care JASMINE JEWEL HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bfc8a200-8431-4f33-8765-4576278850d52026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET PEA GARDEN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.9bce280b-6692-4d89-a103-fec8e5ecdb0e2026-01-16WarningsExact identifier
unii: 3K9958V90M
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4868de4b-65ea-01ed-e063-6294a90ae5512026-01-15WarningsExact identifier
unii: 3K9958V90M
hi peach layneETHYL ALCOHOLZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD486ee2e0-2222-0574-e063-6294a90a9eff2026-01-15WarningsExact identifier
unii: 3K9958V90M
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
BIOPURE Hand Sanitizer Spray-Coastal GlowHAND SANITIZER SPRAYQuest USA Corp48254577-9f1e-9389-e063-6394a90a92f12026-01-15WarningsExact identifier
unii: 3K9958V90M
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487a4c8e-4fb3-6bff-e063-6294a90abd532026-01-15WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd3bad0a57-46c8-a529-e063-6294a90a7e2f2026-01-15WarningsExact identifier
unii: 3K9958V90M
Gold Bond Hydrating Hand SanitizerETHYL ALCOHOLChattem, Inc.96fe0191-0d34-4bf3-8f93-0e64764c353a2026-01-14WarningsExact identifier
unii: 3K9958V90M
Smart Care BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.9babb5bd-f32e-4742-879c-eb7171fd71b12026-01-14WarningsExact identifier
unii: 3K9958V90M
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA483f3199-7357-112c-e063-6394a90aafa42026-01-14WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerALCOHOL HAND SANITIZERGuangdong bangze medicine co., ltd2e8b5afe-6ff8-3e9b-e063-6394a90ad7032026-01-14WarningsExact identifier
unii: 3K9958V90M
Alcohol SanitizerALCOHOL SANITIZER SPRAYGuangdong bangze medicine co., ltd2e9db49b-35ce-00d5-e063-6294a90acf352026-01-14WarningsExact identifier
unii: 3K9958V90M
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA48555528-bbbc-ccef-e063-6294a90a66092026-01-14WarningsExact identifier
unii: 3K9958V90M
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4866d108-0bbb-12bf-e063-6394a90a338c2026-01-14WarningsExact identifier
unii: 3K9958V90M
Smart Care MONSTER JAM SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6ed35ced-411a-44ad-8c33-fa900e6502542026-01-13WarningsExact identifier
unii: 3K9958V90M
Perk Hand Sanitizer with MoisturizersALCOHOLWorklifebrands LLC4846937f-905e-faec-e063-6394a90a77a22026-01-13WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHANOLSaraya Healthcare30c68860-c7ff-5dbb-e054-00144ff8d46c2026-01-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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