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 36 of 192 · 3,825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Kick Off ScentedALCOHOLFourstar Group USA, Inc.860f25c3-54b0-4438-ba97-0fc81cf350442026-04-24WarningsExact identifier
unii: 3K9958V90M
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
SOUR LEMON HAND SANITIZER Island Coco ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9e4d9add-0a02-4cce-91e0-7c3ce3ad5cb22026-04-23WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Sugar Lemon ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCObaa5166d-e41f-46aa-adae-038f444bb54e2026-04-23WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST LAVENDER SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited8efafedf-a66e-44a3-b2af-700292f1d0012026-04-23WarningsExact identifier
unii: 3K9958V90M
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMMINOXIDILPutian Licheng District Zhijiancheng Trading Co., Ltd.5009b231-23c3-7356-e063-6394a90a569f2026-04-22WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes LavenderALCOHOLThe Honest Company Inc.4a69b1d5-81ad-2cd1-e063-6294a90ac62d2026-04-22WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes GrapefruitALCOHOLThe Honest Company Inc.4aa8c899-e5c3-9eec-e063-6294a90a6eae2026-04-22WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Golden Tangerine ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO82c7f67c-dca8-4859-b945-db34a039cc3d2026-04-22WarningsExact identifier
unii: 3K9958V90M
3M Avagard DALCOHOLSolventum US LLC220c8a49-2a52-4660-8ad4-de553bd032262026-04-22WarningsExact identifier
unii: 3K9958V90M
3M AvagardCHLORHEXIDINE GLUCONATE AND ALCOHOLSolventum US LLC8bf8fe8e-76cb-4eda-a18d-1687050285ae2026-04-22WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited0f96981b-6ba0-4993-b35e-4d430b0f44ff2026-04-22WarningsExact identifier
unii: 3K9958V90M
Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry CrumbleALCOHOL SPRAYScent Theory Products LLC4ffa6e26-870f-586e-e063-6394a90ad9752026-04-21WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLTarget Corporation5c6be1e4-ae02-430c-8ed7-2148660da19d2026-04-21Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
unii: 3K9958V90M
Smart Care APPLE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3a377d37-28c3-4cd6-8633-8b13464a28ef2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.24534267-52d9-47c9-bb83-913c3a0f29d12026-04-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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