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 172 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Super Leaves Hand Sanitizer Olive LeavesETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d2fef3-00b3-9ee1-e063-6394a90ae3442023-12-11WarningsExact identifier
unii: 3K9958V90M
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
unii: 3K9958V90M
HAN-I-SIZEHAN-I-SIZEMomar, Inc.05e1f56d-2ee9-d13f-e063-6294a90afc912023-12-11WarningsExact identifier
unii: 3K9958V90M
INSTANTINSTANTUltra-Chem, Inc.0c425c6e-6c05-1748-e063-6394a90a9b5e2023-12-11WarningsExact identifier
unii: 3K9958V90M
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
unii: 3K9958V90M
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEA-S Medication Solutionsa1ebb51e-4658-4852-bf90-1983a3d447832023-12-10Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
unii: 451W47IQ8X
Algonquin HanSanALCOHOLWhisk Products, Inc.1808f5ab-4bee-4768-995b-911b10cfa18b2023-12-08WarningsExact identifier
unii: 3K9958V90M
D-GermALCOHOLWhisk Products, Inc.fe08fb0c-007c-40a7-e053-6294a90acac92023-12-08WarningsExact identifier
unii: 3K9958V90M
Pacific Breeze Instant Hand Sanitizer GelALCOHOLWhisk Products, Inc.3f574300-b05a-4f98-98fa-dd2177bb3d752023-12-08WarningsExact identifier
unii: 3K9958V90M
Pretty Pump Hand SanitizerALCOHOLWhisk Products, Inc.c6d6ca9a-9fe7-4a6d-8179-e085a4b414c82023-12-08WarningsExact identifier
unii: 3K9958V90M
AP HanSanALCOHOLWhiskProducts, Inc.e212fd90-f4e4-44c4-bfb7-16e313c30be92023-12-07WarningsExact identifier
unii: 3K9958V90M
Aire-Master Waterless Hand SanitizerALCOHOLWhisk Products, Inc.8f0b77b1-ef16-4a3c-874b-07f78d6a45b72023-12-07WarningsExact identifier
unii: 3K9958V90M
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
unii: 3K9958V90M
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
ALCOHOL ANTISEPTIC HAND SANITIZERALCOHOLCustom Quest, Inc.70dd10e3-1958-43a6-af7e-29ca900b00f62023-12-04WarningsExact identifier
unii: 3K9958V90M
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDb57c7e3a-f0bf-fd42-e053-2a95a90a3b4f2023-12-01WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLASC Marketing LTDb57c8ae8-dfb1-a959-e053-2995a90abddf2023-12-01WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56d6034-cac2-a9e2-e053-2a95a90aebf02023-12-01WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56dc975-af3c-fdbe-e053-2a95a90a647b2023-12-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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