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 80 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462a1437-154c-0324-e063-6294a90a12662025-12-17WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLSolupharm Pharmazeutische Erzeugnisse GmbH372d3eb5-78ee-414c-a146-4a19e22661842025-12-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 451W47IQ8X
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 451W47IQ8X
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
Vital-FLBODY FLUID BALANCEVitaltiy Works, Inc.13207197-7ef7-49a3-8970-5f98299a75d22025-12-17WarningsExact identifier
unii: 451W47IQ8X
Kay Hand Sanitizer FoamETHYL ALCOHOLEcolab Inc.f82eaaaf-cead-497a-8b95-9668310511872025-12-17WarningsExact identifier
unii: 3K9958V90M
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: 451W47IQ8X
Keystone Liquid Hand SanitizerALCOHOLEcolab Inc.1d808912-f1ad-4eed-a52d-6c6a363ddba22025-12-16WarningsExact identifier
unii: 3K9958V90M
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 451W47IQ8X
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: 451W47IQ8X
IODIUM HPBARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROIDNatural Creations, Inc.9353d604-e168-4df1-9726-e965c9fc2c782025-12-16WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: 451W47IQ8X
EcolabALCOHOLEcolab Inc.69962e54-2e1f-404a-b039-5ebf77cabd5f2025-12-16WarningsExact identifier
unii: 3K9958V90M
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: 451W47IQ8X
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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