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 28 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de8eef-b344-3e25-e063-6394a90a01d82026-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitize Caramel LatteALCOHOLShenzhen Lantern Scicence Co.,Ltd.53df1a36-9b0a-4696-e063-6394a90a91a42026-06-09WarningsExact identifier
unii: 3K9958V90M
ApizelenGERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUMBioActive Nutritional, Inc.471a7fab-1ef1-4d13-a28e-75f9762a711a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
MISTIFY COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006e7bf-96f6-1faa-e063-6394a90ab5a32026-06-08WarningsExact identifier
unii: 3K9958V90M
Walgreens VANILLA Hand Sanitizer MistETHYL ALCOHOLWalgreen Company7c083331-3d5f-4248-8b2c-3e7e1b266a792026-06-05WarningsExact identifier
unii: 3K9958V90M
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.26a1761b-90bf-49c6-9e6a-f293af2296ce2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
unii: 4EVE5946BQ
Signature Series Enriched Foam Alcohol Hand SanitizerALCOHOLCintas3633620e-5057-469c-91a5-c628d1c90aca2026-06-05WarningsExact identifier
unii: 3K9958V90M
VANILLA SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limited67c2cb48-481d-41aa-a11d-e00d81d7a34a2026-06-05WarningsExact identifier
unii: 3K9958V90M
TC Enriched Foam Alcohol Hand SanitizerALCOHOLRubbermaid Commercial Products LLC4f3f0d3f-39c6-4ad4-9cb0-6e0d7b568e512026-06-04WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf335a030-ffa8-4f42-8166-2f06e036b40d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665461
unii: 4EVE5946BQ
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
STRAWBERRY SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limited8c9ddf82-fcc8-4575-8a3a-ce11542c3ab42026-06-03WarningsExact identifier
unii: 3K9958V90M
WATERMELON SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limitedf49efe3b-5ad7-4658-a1a7-1e46f48d17842026-06-03WarningsExact identifier
unii: 3K9958V90M
CUPCAKE SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limitedd1d92aa2-23e6-4c0f-a3da-e00536b606752026-06-03WarningsExact identifier
unii: 3K9958V90M
ATTITUDE Little leaves Hand Sanitizer Vanilla and PearETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09bee97d-a8e4-7c9c-e063-6294a90a04122026-06-02WarningsExact identifier
unii: 3K9958V90M
PESI VANILLA HYDRATIING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53325d04-26db-fc62-e063-6394a90a322a2026-06-01WarningsExact identifier
unii: 3K9958V90M
KOOL AID PPINK LEMONADE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53342b67-8742-1387-e063-6394a90acc742026-06-01WarningsExact identifier
unii: 3K9958V90M
ICEE CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53352f95-6477-25e3-e063-6394a90a9e022026-06-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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