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 7 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTOR INKS HAND SANITIZERBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Ince174f231-73df-464b-bd92-23222659df242026-07-21WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Sanitizing Hand WipesBENZALKONIUM CHLORIDEENVIRO SPECIALTY CHEMICALS INCea99c72e-1881-498a-a653-29bac1dab97b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial with Moisturizers Crisp Clean LHSBENZALKONIUM CHLORIDEColgate-Palmolive Company7e978e04-9b1a-44ef-b082-429a6a7520282026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers White Tea and Berry FusionBENZALKONIUM CHLORIDEColgate-Palmolive Company804d6674-bd6c-4533-89c2-8c82de92a0772026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Fresh CitrusBENZALKONIUM CHLORIDEColgate-Palmolive Companyb1352731-9050-4e1b-a292-ab921c22160f2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Germ Free 24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfa0cb8a1-d58a-4c7a-928e-2b071d9dd3ee2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Crisp CleanBENZALKONIUM CHLORIDEColgate-Palmolive Company65d4de78-fa6f-4838-8217-0e3599cc09a02026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd56dc7a8-bee3-4eca-95cf-f1b0a6e2aad22026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.8accbb78-fc64-45d5-69b0-35c23a1d2a2e2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
unii: F5UM2KM3W7
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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