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 98 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mild iodine tinctureIODINE AND SODIUM IODIDE AND ALCOHOLBIONPHARMA INC.3ed930e0-0e73-277b-e063-6394a90a1b312025-10-06WarningsExact identifier
unii: 3K9958V90M
Purforma Advanced Hand Sanitizer 70% AlcoholHAND SANITIZER 70% ALCOHOLSpartan Chemical Company, Inc.06bd825d-914f-5ca7-e063-6394a90aec492025-10-06WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER SWEET PEONYETHYL ALCOHOLPearl World Inc.d8530009-be78-4a06-851a-f2de0f9b5fdb2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST LAVENDER SCENTETHYL ALCOHOLPearl World Inc.59d76f20-ca26-4cb2-b929-f8ae7c281f3e2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT LIME SCENTETHYL ALCOHOLPearl World Inc.d47930c5-ea4e-43a5-8654-ca4f9d391c2d2025-10-06WarningsExact identifier
unii: 3K9958V90M
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA, Inc.b1c8e5d0-a766-4bf0-a385-b7b8940a0e2c2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.a0df14cd-50a3-48ba-8510-f04276793acc2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST OCEAN BREEZE SCENTETHYL ALCOHOLPearl World Inc.2d37bdef-2927-4d5c-906d-4f6563524cdd2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA SUGAR SCENTETHYL ALCOHOLPearl World Inc.0c5c7939-b2ba-47b6-bb51-39920e320f952025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.fd522416-b585-4426-ac0b-fb363d8ae5922025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SWEET PEONY SCENTETHYL ALCOHOLPearl World Inc.1fbe93d5-8af2-41ca-b516-98729655d2d42025-10-03WarningsExact identifier
unii: 3K9958V90M
Zylast AntisepticETHYL ALCOHOLInnovative BioDefense178190dc-7c68-6485-e054-00144ff8d46c2025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c77ae-e9ff-4656-e053-2995a90a16d42025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand SanitizerALCOHOLInnovative Biodefense, Incd91b6278-864e-477a-e053-2a95a90aabd92025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c5753-eb27-1d1c-e053-2a95a90a888a2025-10-02WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LP38fc11a0-50d1-4ba5-8d46-331eb74a00d62025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SCENTETHYL ALCOHOLPearl World Inc.36853a90-74fa-4427-814a-d703e68a6dde2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MIXED BERRY SCENTETHYL ALCOHOLPearl World Inc.f48def31-3a9c-49fb-817b-5fca781ad88a2025-10-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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