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 56 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Moisturizing Hand Sanitizer Champagne ToastALCOHOLBath & Body Works, Inc.29294e13-e196-3ca2-e063-6294a90a92e02026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Mahogany TeakwoodALCOHOLBath & Body Works, Inc.1bb85c27-d855-49c0-e063-6394a90a6a512026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Sunshine and LemonsALCOHOLBath & Body Works, Inc.1bb99458-e528-d241-e063-6394a90a58b12026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Fresh Cut LilacsALCOHOLBath & Body Works, Inc.387be420-3943-10ed-e063-6294a90ab79c2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Blueberry BelliniALCOHOLBath & Body Works, Inc.387c9fca-3d39-2553-e063-6394a90a922d2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Strawbery KiwiALCOHOLBath & Body Works, Inc.29a24b5e-fbef-bb91-e063-6294a90af5322026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Beautiful DayALCOHOLBath & Body Works, Inc.387ca6e9-38eb-2519-e063-6394a90a42112026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Iced Lemon Pound CakeALCOHOLBath & Body Works, Inc.387ca6e9-38ec-2519-e063-6394a90a42112026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Rose Water and IvyALCOHOLBath & Body Works, Inc.387caf6b-fd9c-a63f-e063-6294a90a041a2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Fresh Coconut and CottonALCOHOLBath & Body Works, Inc.29a27bb2-2edd-6e6d-e063-6394a90a4fb22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Pomegranate and BlackberryALCOHOLBath & Body Works, Inc.387ca290-1d8a-abb7-e063-6294a90a12ff2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Afternoon Apple PickingALCOHOLBath & Body Works, Inc.369ac581-c59b-4eb5-e063-6394a90aec7a2026-03-02WarningsExact identifier
unii: 3K9958V90M
Allergy Relief Indoor and OutdoorALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NAPHTHALINUM, NATRUM MURIATICUM, SABADILLA, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, AND WYETHIA HELENIOIDES.King Bio Inc.9faa963e-4ddc-461f-95a1-2d10e12606122026-03-02WarningsExact identifier
unii: 451W47IQ8X
HAND SANITIZER lsland CoconutALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf3a822-27d2-efef-e063-6294a90a05022026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Cherry BlossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf48a93-345d-b901-e063-6394a90ab41b2026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Cucumber MelonALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf552a4-b8b3-6fe3-e063-6394a90a722a2026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
unii: 3K9958V90M
LibidotoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIAEnergique, Inc.4ceacaa0-0219-421a-8fff-c1784c3d0f702026-02-27WarningsExact identifier
unii: 451W47IQ8X
Hand SanitizerETHYL ALCOHOLThe Kroger Co.9f95d956-25db-4ffa-86cc-a160677124b82026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLThe Kroger Co.a848de11-0438-400b-b363-df595692685a2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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