FDA.reportPublic FDA data

NDC 60505-1003-01 - 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
60505-1003
Requested NDC
60505-1003-01
Package NDCs from labels
60505-1003-1, 60505-1003-2, 60505-1003-01
Manufacturer
Apotex Corp.
Effective date
2026-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Apotex Corp.Apotex Corp.2026-07-16HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2025-07-31HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Redpharm DrugRedpharm Drug2024-07-03HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-05-30HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Proficient Rx LPProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - A-S Medication SolutionsA-S Medication Solutions2021-04-15HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2020-06-19HUMAN PRESCRIPTION DRUG LABEL
KETOROLAC TROMETHAMINE - DIRECT RXDIRECT RX2019-10-30HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Medsource PharmaceuticalsMedsource Pharmaceuticals2018-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-1003-1Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS513
60505-1003-1Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS113
60505-1003-2Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS113
60505-1003-2Ketorolac Tromethamine10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1003KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]11Current NDC, Legacy NDC, 4 package rows20240927_d9a186ba-74a9-b6d4-1109-1e045ba1763e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1003-1ML - Milliliter60505-10039242ed86-ca0a-4b36-8ca2-eba63b8be90312012-07-24
60505-1003-2ML - Milliliter60505-1003b5119ae4-e5cf-48d3-8cc5-8eeb4fe10e6712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
KetorolacACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
OCTOXYNOL-40INACTIVE INGREDIENT9T1C662FKSKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6

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 3 of 118 · 2,345 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug59d86768-6214-8389-e063-6394a90a0a3d2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 860107
unii: 4EVE5946BQ
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
unii: F5UM2KM3W7
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
unii: F5UM2KM3W7
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
unii: F5UM2KM3W7
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial Clean and Protect Cool SplashBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANY7d48e018-0874-4bbf-a95e-dc21702406c12026-08-20WarningsExact identifier
unii: F5UM2KM3W7
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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