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 64 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INSTANT HAND SANITIZERINSTANT HAND SANITIZERNINGBO MEITELI COSMETICS CO., LTD49e44671-5d79-aa8e-e063-6294a90a9d2e2026-02-02WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINECivica, Inc.32198544-4a46-495c-ab65-0836dcbc2c492026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug49ade79d-4d23-6611-e063-6294a90adfaa2026-01-31Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
BCBGENERATION Hand Sanitizer WHITE JASMINE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2c904dad-b8d9-49c5-9cbf-b5916f05c2c12026-01-31WarningsExact identifier
unii: 3K9958V90M
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Advanced Hand SanitizerALCOHOLRite Aid Corporationf7eb3c0e-4e53-45d8-88f9-95026f5e3efb2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLRite Aid Corporation5f474ef9-0459-4192-b31d-cbf69c7a2b9a2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SOUR LEMON Hand Sanitizer MARSHMALLOW SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3ce38e8c-8f57-480b-86be-8bf7681bbb882026-01-30WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
unii: 3K9958V90M
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
AlcoholALCOHOLAldi, Incaaa55815-ab6d-41c0-b04f-53de8001ebc72026-01-29WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLAmerisource Bergene2718f0e-14e9-4698-8400-f5dfe9169bf72026-01-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Ethyl Rubbing AlcoholETHYL ALCOHOLCardinal Health, 110 dba Leaderc56cbcbf-8e0e-4dff-80d3-df420c500a932026-01-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Adventure Hand Sanitizer - Fragrance 80%ALCOHOLNICETY SOLUTIONS LLCa507c20e-37d8-ea80-e053-2a95a90a41d42026-01-29WarningsExact identifier
unii: 3K9958V90M
Adventure Hand Sanitizer - Unscented 80%ALCOHOLNICETY SOLUTIONS LLCa5077eb2-4adb-0680-e053-2995a90a2cef2026-01-29WarningsExact identifier
unii: 3K9958V90M
ESC Protecting Foam Hand SanitizerALCOHOLEcolab Inc.d0820c4c-b320-4d3d-8ee3-de24fbed227b2026-01-29WarningsExact identifier
unii: 3K9958V90M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Singular Wipes fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLC867a25d2-3d2c-4dad-bbe8-84195c03a87d2026-01-27WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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