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 173 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDbf0098ab-6c0d-ecd2-e053-2a95a90a670c2023-12-01WarningsExact identifier
unii: 3K9958V90M
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
unii: 3K9958V90M
B-Pure Citrus scented Hand SanitizingALCOHOLFourstar Group USA, Inc.809f18fa-46ad-4366-bb76-96ab0e787ded2023-11-30WarningsExact identifier
unii: 3K9958V90M
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.5ca7c520-d099-4900-9e37-7f624397e5782023-11-30WarningsExact identifier
unii: 3K9958V90M
B-Pure Citrus Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.0a22230e-d511-041d-e063-6394a90aade92023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef706620b-15b3-4468-e053-6394a90a83172023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef7070892-741f-e528-e053-6294a90aee7a2023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef707644e-aa2c-d80a-e053-6394a90a33312023-11-30WarningsExact identifier
unii: 3K9958V90M
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
Coconut Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.95d41ada-68fc-44bf-bf34-1904d5b0dc452023-11-29WarningsExact identifier
unii: 3K9958V90M
Natural Extensions Fragrance- Free Instant Hand SanitizerALCOHOLBenco Dentalb1f10f16-8269-402a-9646-32dbfdef1ffc2023-11-28WarningsExact identifier
unii: 3K9958V90M
Zogics Instant Hand Sanitizer Hydrating GelALCOHOLZogics, LLC29c5f277-7b8a-4f38-8a09-33139f27c9102023-11-28WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackf713500a-20b8-8e20-c4cc-9568051703352023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepack9e5fde54-2206-4072-afb8-4d06a8d314b12023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Alcohol WipesALCOHOLShaoxing Elite Bio-Tech Co.,Ltd.b42c2735-ead2-4db9-e053-2a95a90a229f2023-11-22WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Vampire BloodALCOHOLBath & Body Works, Inc.0aac0b96-e477-173c-e063-6294a90a9a162023-11-21WarningsExact identifier
unii: 3K9958V90M
B-Pure Coconut Scented Hand SanitizingALCOHOLFourstar Group USA, Inc.52b21789-d544-451e-b54a-4e2b4b85f4452023-11-21WarningsExact identifier
unii: 3K9958V90M
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.c82c37d7-d8fd-4411-a18f-fab4d1eaa2a92023-11-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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