FDA.reportPublic FDA data

NDC 0641-6043-01 - 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
0641-6043
Requested NDC
0641-6043-01
Package NDCs from labels
0641-6043-01, 0641-6043-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - A-S Medication SolutionsA-S Medication Solutions2021-06-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6043-01Ketorolac Tromethamine2 mL in 1 VIALINJECTION213
0641-6043-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6043KETOROLAC TROMETHAMINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20240411_0c2c75c9-ed7b-46a8-9543-429bf2d8f090.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6043-01ML - Milliliter0641-604336c45488-a54c-43b3-84ee-8e73c00410a912013-02-13
0641-6043-25ML - Milliliter0641-60432417a382-ad3f-43d9-af6d-fd60b4dd63a712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

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 58 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Hand SanitizerADVANCED HAND SANITIZERChain Drug Marketing Association49a1001c-8f4e-d0e7-e063-6394a90a53062026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLChain Drug Marketing Associationa85d93f2-e6f0-4fad-9ff7-6cbb62942bb22026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AdvancedETHYL ALCOHOLPerrigo Direct, Inc68eca241-acce-4f12-9643-bec9b14f53d02026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLMeijer, Inc.a56b4a66-3923-4e40-a461-1d97043fb89a2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Eucalyptus and SpearmintALCOHOLBath & Body Works, Inc.38d5ca92-2518-3dc4-e063-6394a90a2bc02026-02-19WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLMeijer, Inc.dd0bf473-b036-4a72-8caf-d9624d840fad2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLMeijer, Inc.6f6db114-c474-4b4b-971f-01743850cf3c2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer STRAWBERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe083f131-4b1c-42b5-947a-c4705d4fb00d2026-02-19WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEMajor Pharmaceuticals48245718-a2df-4938-8d06-3b8abf34181e2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
PDI Alcohol Prep Pad Sterile Large and MediumALCOHOLProfessional Disposables International Inc8fe9cf1c-3f5f-4873-9648-6d4c79f8cf032026-02-18WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLTarget Corporatione877e196-fa56-42e2-8b32-4509b1be85752026-02-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLS. P. Richards Company8d88285b-83d5-4089-bb8d-839537ae06f52026-02-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
BCBG GENERATION HAND SANITIZER MALIBU Peach SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO8579e94a-b83d-4720-838e-a36368642deb2026-02-18WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION HAND SANITIZER PINK Guava SCENTETHYL ALCOHOLDIAMOND LIFE COSMETICS TRADING FZCOe950cb8f-b6dc-4cde-8027-e5ca1c0e4e222026-02-18WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer JUNIPER BERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOf5693209-7adf-43fd-87b1-1c8819c2db6c2026-02-17WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA HEAVEN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.19163896-3ac4-413d-8072-53776712f3cd2026-02-17WarningsExact identifier
unii: 3K9958V90M
Smart Care ISLAND MANGO HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.71e3d290-452d-4854-9ce5-47041f7472502026-02-17WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer with AloeALCOHOLUpLift Brands, LLC3b4d4901-cf7d-4048-8a24-cfb00fd8b1082026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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