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 79 of 188 · 3,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Gel Hand SanitizerALCOHOLEcolab Inc.c69b563d-ea9d-4ebc-b9ca-b84bd4e0de852025-12-10WarningsExact identifier
unii: 3K9958V90M
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLC1a8cb031-5608-400f-b924-feb6bbd17fa12025-12-09WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINESOLA Pharmaceuticals, LLC2301a6a2-b88a-4c0d-bb6c-ad4a8af7da392025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINESOLA Pharmaceuticals, LLCb08a46f3-36c9-405d-a963-9739a5c87f9c2025-12-08Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
unii: 3K9958V90M
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
unii: 3K9958V90M
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
unii: 3K9958V90M
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
Ketorolac TromethamineKETOROLAC TROMETHAMINEChartwell RX, LLC3855f527-fd6c-4f24-a4b4-cd47eec1193d2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 451W47IQ8X
Mrs. Meyers Clean Day Hand Sanitizer Basil ScentALCOHOLThe Caldrea Companyd263d012-997c-4029-b771-e8f346da59882025-12-04WarningsExact identifier
unii: 3K9958V90M
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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