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#

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 55 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-BacterialHandSpray Lavender and VanillaALCOHOLBath & Body Works, Inc.29a37aad-c6d3-b174-e063-6394a90abc3e2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Lavender and VanillaALCOHOLBath & Body Works, Inc.38d5a11f-d0cb-30eb-e063-6394a90a6a492026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.2b0f3ca1-0a68-08a6-e063-6294a90a9df22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.38e1c1d6-6511-4066-e063-6294a90ad3f42026-03-02WarningsExact identifier
unii: 3K9958V90M
Ethyl AlcoholETHYL ALCOHOLOld East Main Co.479d5880-1e7e-481e-98df-dd98324d6ab82026-03-02Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray White T ShirtALCOHOLBath & Body Works, Inc.29a38d22-0685-37af-e063-6294a90a31e62026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Passionfruit and Banana FlowerALCOHOLBath & Body Works, Inc.38d5d6c2-8ceb-40b7-e063-6394a90a2a8f2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray A Thousand WishesALCOHOLBath & Body Works, Inc.29a3aac8-2083-3ece-e063-6394a90ab4402026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray OceanALCOHOLBath & Body Works, Inc.29a38d22-068a-37af-e063-6294a90a31e62026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Champagne ToastALCOHOLBath & Body Works, Inc.29a3aa8a-c697-a873-e063-6294a90a72c42026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Peach BelliniALCOHOLBath & Body Works, Inc.297e26d2-128e-0aa5-e063-6294a90a34dc2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Waikiki Beach CoconutALCOHOLBath & Body Works, Inc.38d5cfd5-db0d-4735-e063-6394a90a42a82026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Sunshine and LemonsALCOHOLBath & Body Works, Inc.297e95be-a862-9d13-e063-6294a90a9faa2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Sweet Kiwi and StarfruitALCOHOLBath & Body Works, Inc.38d5d1c4-7f5b-45af-e063-6394a90a9c472026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray OceanALCOHOLBath & Body Works, Inc.38d5c6ac-4e71-3e9e-e063-6394a90af6c22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Fresh RainfallALCOHOLBath & Body Works, Inc.29a359fa-66e9-a7d3-e063-6294a90a6d722026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38951e2b-0334-2970-e063-6394a90a6b442026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Mahogany TeakwoodALCOHOLBath & Body Works, Inc.38d5c6ac-4e73-3e9e-e063-6394a90af6c22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.38d5df93-a95e-9980-e063-6294a90a20a22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray In The StarsALCOHOLBath & Body Works, Inc.29a3b5b3-c103-7754-e063-6294a90af8e72026-03-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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