FDA.reportPublic FDA data

NDC 60505-1003-02 - 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
60505-1003-02
Package NDCs from labels
60505-1003-1, 60505-1003-2, 60505-1003-02
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 1 of 119 · 2,367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
North Woods Derma Foam Hand SanitizerBENZALKONIUM CHLORIDESuperior Chemical Corporationad51a175-2b91-fd14-e053-2995a90ad54d2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: F5UM2KM3W7
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
ketorolac tromethamineKETOROLAC TROMETHAMINESportpharm LLC2a23b0fa-803c-4abb-b588-12cfe83326a92026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
unii: F5UM2KM3W7
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
unii: F5UM2KM3W7
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.6f727e1f-2838-427b-a236-eeb0101b08f32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEREMEDYREPACK INC.cdd4d548-33f8-42d6-8eae-e36aa577c0502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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