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 137 of 200 · 3,984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Cucumber MelonALCOHOLBath & Body Works, Inc.29a63c54-116f-30bb-e063-6394a90a8c6f2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Frosted Coconut SnowballALCOHOLBath & Body Works, Inc.29a652a8-15fd-80d4-e063-6394a90acb4d2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Black Cherry FrostALCOHOLBath & Body Works, Inc.29a654df-016b-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Winterberry IceALCOHOLBath & Body Works, Inc.29a64c95-eb54-8081-e063-6394a90a07262024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Magic In The AirALCOHOLBath & Body Works, Inc.29a651e4-a014-57d2-e063-6394a90a35f02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.29a64de5-af39-5a91-e063-6394a90ac35c2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Honolulu SunALCOHOLBath & Body Works, Inc.29a64c62-8517-1b39-e063-6294a90a35a82024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry SnowflakesALCOHOLBath & Body Works, Inc.29a651e4-a016-57d2-e063-6394a90a35f02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowflakes and CashmereALCOHOLBath & Body Works, Inc.29a654df-0169-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: 451W47IQ8X
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
unii: 451W47IQ8X
eZFoam Foaming Alcohol Hand SanitizerFOAMING HAND SANITIZERKutol Products Company1f56b4c5-d703-4193-83a8-3be815c8acda2024-12-18WarningsExact identifier
unii: 3K9958V90M
Santi-Gel Instant Hand SanitizerSANTI-GEL INSTANT HAND SANITIZERKutol Products Company, Inc.f5bb2593-e036-4586-a807-2049e06b24752024-12-18WarningsExact identifier
unii: 3K9958V90M
Walgreens Saline Mist Extra StrengthSODIUM CHLORIDEWalgreen's Corporation90cbe2dc-36b6-77fb-e053-2995a90a28972024-12-18WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy6f1fe980-ca09-401d-aed6-d3d3387cc49a2024-12-18WarningsExact identifier
unii: 451W47IQ8X
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
unii: 3K9958V90M
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
unii: 3K9958V90M
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
unii: 3K9958V90M
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: XF417D3PSL
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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