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 35 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kleenex Ultra Moisturizing Hand SanitizerALCOHOLKimberly-Clark Corporation75e884bf-8e0d-41e7-adbb-4400ee3d1e072026-05-08WarningsExact identifier
unii: 3K9958V90M
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
XHC-075ALCOHOLEcolab Inc.708d0018-372b-4fde-b408-f4be030f26632026-05-07WarningsExact identifier
unii: 3K9958V90M
Natural Concepts Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Careb25bbf28-f08d-4de2-9be7-bfb6b134b49a2026-05-07WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGiant Eagled384d3f3-a3c8-a98d-e053-2995a90ab9bf2026-05-07WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.fb93b4f6-9eaf-4c35-a110-1f526ca7c3732026-05-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.57f60d9e-954d-413d-ab3b-e4b800d072bf2026-05-06WarningsExact identifier
unii: 3K9958V90M
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsExact identifier
unii: 3K9958V90M
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
unii: 3K9958V90M
GuardALCOHOLApollo Health and Beauty Carefdc99948-1bd0-cdf2-e053-6394a90aaf972026-05-05WarningsExact identifier
unii: 3K9958V90M
MoxieETHYL ALCOHOLApollo Health and Beauty Care3752d034-d4b4-47ab-b1bb-066cef7fde752026-05-05WarningsExact identifier
unii: 3K9958V90M
AlcoholETHYL ALCOHOLSam's West Inc16625ecb-11c3-a097-e063-6294a90af3d52026-05-05WarningsExact identifier
unii: 3K9958V90M
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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