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 139 of 200 · 3,984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Dazzling DiamondALCOHOLBath & Body Works, Inc.29291436-743c-c425-e063-6394a90a71652024-12-13WarningsExact identifier
unii: 3K9958V90M
Alcare Enhanced Foaming Hand SanitizerALCOHOLSC Johnson Professional USA Inc.7180c18f-d436-4daf-9fec-7e73664228022024-12-13WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINETeva Pharmaceuticals USA, Inc.688f5dec-a6db-43c6-a1f8-5df99d08d3952024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Foaming Hand SanitizerALCOHOLEmpack Spraytech Inc.8bb072f2-9cd4-499d-9d7f-7166451b8f202024-12-12WarningsExact identifier
unii: 3K9958V90M
Extra Stength Hand Sanitizer Zytec Germ BusterALCOHOL 80%W/WEmpack Spraytech Inc.da854195-3a50-4fae-a5ea-183bf524c9732024-12-12WarningsExact identifier
unii: 3K9958V90M
Zytec Hand Sanitizer Wipes 80% w/w AlcoholALCOHOLEmpack Spraytech Inc.ab86fd0c-40cd-0bb6-e053-2a95a90a76e22024-12-12WarningsExact identifier
unii: 3K9958V90M
Smart San Hand SanitizerALCOHOLBest Sanitizers, Inc.b76459d8-747b-86f9-e053-2a95a90ab6542024-12-12WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizing WipeALCOHOLGOJO Industries, Inc.e1ad4ebd-63bb-4a39-83b9-c806e10a600d2024-12-12WarningsExact identifier
unii: 3K9958V90M
PURELL Cottony Soft Hand Sanitizing WipeALCOHOLGOJO Industries, Inc.fc19689f-4826-4adf-8292-ea002cc4ad052024-12-12WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced E3 Rated Instant Hand Sanitizer FoamALCOHOLGOJO Industries, Inc.1f78370b-132a-4759-8cbc-b5e093f90f8d2024-12-12WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sun-Ripened RaspberryALCOHOLBath & Body Works, Inc.28edbdd5-f542-8409-e063-6394a90afc582024-12-11WarningsExact identifier
unii: 3K9958V90M
PURELL Healthcare Advanced Hand Sanitizer GelALCOHOLGOJO Industries, Inc.e3eef311-7515-46e8-8643-ead7905961842024-12-11WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC2900e69d-29ec-210a-e063-6294a90a50082024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
unii: 4EVE5946BQ
Purell Advanced Moisturizing 2in1ALCOHOLGOJO Industries, Inc.950002ed-f3a2-4ede-98fe-762ee9f018b92024-12-11WarningsExact identifier
unii: 3K9958V90M
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
unii: XF417D3PSL
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
unii: XF417D3PSL
Optimize Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b9348-c35f-7ba9-e053-2995a90a4a302024-12-11WarningsExact identifier
unii: 3K9958V90M
PURELL Healthcare Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.4fa85619-257f-4a19-a8f2-5a2e4b8097262024-12-11WarningsExact identifier
unii: 3K9958V90M
ZOEY naturals Island Hibiscus HAND SANITIZERETHYL ALCOHOLAbsolutely Natural, Inc.2829dec2-1425-4ac3-812b-f45abd7ec4262024-12-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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