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 5 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
unii: F5UM2KM3W7
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact identifier
unii: F5UM2KM3W7
antibacterial wipes 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.585dec39-ccb8-d2ba-e063-6394a90aec0f2026-08-06WarningsExact identifier
unii: F5UM2KM3W7
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Giant EagleBENZALKONIUM CHLORIDEApollo Health and Beauty Care4d2aecfb-8865-bf54-e063-6394a90aec632026-08-05WarningsExact identifier
unii: F5UM2KM3W7
Wound Wash Antiseptic Saline with Benzalkonium ChlorideWOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDENeilMed Pharmaceuticals, Inc.55a1fc63-2527-4033-e054-00144ff8d46c2026-08-05WarningsExact identifier
unii: F5UM2KM3W7
Wish Sanitizing Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.c81c0924-bb01-4fa2-b933-8777358e45e72026-08-05WarningsExact identifier
unii: F5UM2KM3W7
Medi-First Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd31fe110-6d75-bf15-e053-2a95a90a86942026-08-03WarningsExact identifier
unii: F5UM2KM3W7
Strawberry Shortcake Raspberry Hand Sanitizer WipesHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd598dcab0-ff1f-19ad-e063-6394a90ad6842026-08-01WarningsExact identifier
unii: F5UM2KM3W7
Strawberry Shortcake Berry Twist Hand Sanitizer WipesHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd598df8ff-6526-3d6d-e063-6394a90a056f2026-08-01WarningsExact identifier
unii: F5UM2KM3W7
Strawberry Shortcake Strawberry Hand Sanitizer WipesHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd598e08a1-3f78-47fe-e063-6394a90a645b2026-08-01WarningsExact identifier
unii: F5UM2KM3W7
Zoono Hand SanitizerBENZALKONIUM CHLORIDEZoono Holdings USAb48c9a16-5027-1fdb-e053-2a95a90a54892026-07-31WarningsExact identifier
unii: F5UM2KM3W7
Zoono Wound CleanserBENZALKONIUM CHLORIDEZoono Holdings USA LLC41fae81e-a2f5-1c07-e054-00144ff8d46c2026-07-31WarningsExact identifier
unii: F5UM2KM3W7
Zoono Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEZoono Holdings USA LLCb4dcfd0f-e3b6-a7e9-e053-2a95a90a56c82026-07-31WarningsExact identifier
unii: F5UM2KM3W7
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BIOPURE50CT ANTI BACTERIAL HAND WIPESBIOPURE50CT ANTI BACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd57d3e290-1343-4075-e063-6394a90a41a62026-07-30WarningsExact identifier
unii: F5UM2KM3W7
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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