FDA.reportPublic FDA data

NDC 0641-6043-01 - 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
0641-6043
Requested NDC
0641-6043-01
Package NDCs from labels
0641-6043-01, 0641-6043-25
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 - A-S Medication SolutionsA-S Medication Solutions2021-06-14HUMAN 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
0641-6043-01Ketorolac Tromethamine2 mL in 1 VIALINJECTION213
0641-6043-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6043KETOROLAC 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
0641-6043-01ML - Milliliter0641-604336c45488-a54c-43b3-84ee-8e73c00410a912013-02-13
0641-6043-25ML - Milliliter0641-60432417a382-ad3f-43d9-af6d-fd60b4dd63a712013-02-13

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 95 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC63b73913-246d-4e5b-bdc9-c202980d87772025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665461
unii: 4EVE5946BQ
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: XF417D3PSL
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
TROPICAL TOUCH HAND SANITIZER HIBISCUS SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOb9d85c14-131e-44c2-9ca8-d707b50f24b32025-10-17WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION HAND SANITIZER TOASTED VANILLA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO33c752a5-e5b3-4c09-b410-e0c09c165e372025-10-16WarningsExact identifier
unii: 3K9958V90M
Meijer Hand Sanitizer Lakeshore FreshALCOHOLShenzhen Lantern Scicence Co.,Ltd.41533b69-05e7-d5f7-e063-6294a90a2d2b2025-10-16WarningsExact identifier
unii: 3K9958V90M
Meijer Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.4153ac2a-e51c-f167-e063-6394a90a80d82025-10-16WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.1bf02dec-ecea-4bbd-94e2-cfafbc43e8852025-10-16WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION PURE FRESHNESS HAND SANITIZER HIBISCUS SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO4799a403-dfcb-4324-8ac9-ac56a99097cf2025-10-16WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION HAND SANITIZER AMBER AND LAVENDER SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOc0edb6a8-8687-48a5-81d8-2a97d79502d82025-10-16WarningsExact identifier
unii: 3K9958V90M
SOFT TOUCH HAND SANITIZER PEONY BLUSH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2d7dfba8-8607-4e4e-adf3-8cdbee0d10342025-10-16WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.412e961a-b7d4-b1c2-e063-6294a90a6b852025-10-15WarningsExact identifier
unii: 3K9958V90M
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
BCBGENERATION HAND SANITIZER COCONUT WATER SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe96b8df6-0b8b-4b2a-806d-f65b85191fc62025-10-15WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions49e04373-568d-48fa-ac1c-b7d6b493e7772025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Smart Care Barbie SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.0d6a56a0-f678-4e23-ac66-aab35c55fbf32025-10-14WarningsExact identifier
unii: 3K9958V90M
Alcohol wipes Hand Sanitizing WipesALCOHOLDGE Essentials Incd14bf315-b0fa-4d3c-9801-e28678818af92025-10-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Crayola ROYAL PURPLE SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4246fbcf-7210-4767-b84b-b7b15ae767952025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Peppa Pig SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.b0e514f4-5342-4e67-9410-c3d6ce9dc9f62025-10-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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