FDA.reportPublic FDA data

NDC 0641-6041-01 - 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
0641-6041
Requested NDC
0641-6041-01
Package NDCs from labels
0641-6041-01, 0641-6041-25
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 Injection, USPGeneral Injectables and Vaccines, Inc.2018-07-02HUMAN 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
0641-6041-01Ketorolac Tromethamine1 mL in 1 VIALINJECTION113
0641-6041-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6041KETOROLAC 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
0641-6041-01ML - Milliliter0641-6041de1e773b-19d1-4632-93ac-345ac50a144912013-02-13
0641-6041-25ML - Milliliter0641-6041ad136187-25b4-4f4d-ab41-60a269c4d8cb12013-02-13

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 176 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerHAND SANITIZERLS PROMOTIONS INC.3f8cae4e-a017-4db6-9a29-ebae65bba34c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLC1f4833c5-fcac-4c01-a5c6-e72837ca0a482023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCa185c9c8-aabe-0e63-e053-2995a90a1b1e2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCce2d6c41-9423-45bd-8cbf-6749fdbb2c9f2023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLProstock LLC9e7d7912-d594-47e9-bd8a-cc4f8ac85b2c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLDegasa, S.A. de C.V.c93048f4-8c26-44c0-a966-7ef8662a7b312023-11-05WarningsExact identifier
unii: 3K9958V90M
Protec Hand Sani Gel AntibacterialALCOHOLDegasa, S.A. de C.V.78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a2023-11-05WarningsExact identifier
unii: 3K9958V90M
Degasa Hand Sanitizer Lemon Lime ScentALCOHOLDegasa, S.A. de C.V.004bfacb-f79a-4f8a-9c8d-1d6e0dde1ce52023-11-05WarningsExact identifier
unii: 3K9958V90M
Iso-Quin hand sanitizerALCOHOLThe Hygenic Company, LLC.d1003c9f-a6f8-3de2-e053-2995a90a6e8a2023-11-05WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLDegasa, S.A. de C.V.6ccffef3-99c6-4663-b9d7-9f50216eb13f2023-11-05WarningsExact identifier
unii: 3K9958V90M
AMBI Soothing Hand sanitizerALCOHOLAMBI Enterprises, llc229a2afd-9f33-42b9-916d-df1e787181f72023-11-05WarningsExact identifier
unii: 3K9958V90M
Justice Cucumber And Melon Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.7823d0de-880e-4c56-acc7-b5c03dbf0e7a2023-11-03WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerINSTANT HAND SANITIZERClark Core Services, LLCbd452261-48f5-56b7-e053-2995a90a6dcf2023-11-02WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTravel Retail Global Inc.62ec5bf1-9467-4c9b-b83d-6709f2146e0a2023-10-31WarningsExact identifier
unii: 3K9958V90M
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
Ahh SleepCOFFEA CRUDAMicro Balance Health Products08ea860f-0183-8ce8-e063-6394a90a582b2023-10-30WarningsExact identifier
unii: QTT17582CB
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb9829141-8222-3381-e053-2995a90ac0332023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic 1 GALLON HAND SANITIZERALCOHOLCleanGenic, LLCb982987b-c462-1ade-e053-2995a90ae6f72023-10-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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