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 140 of 200 · 3,984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Absolutely Natural Cherry Blossom Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.f825e0bf-495f-4bfa-a6e0-5ddbefb37f522024-12-11WarningsExact identifier
unii: 3K9958V90M
Absolutely Natural Rosemary and Mint Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.a7be8b58-8f3e-46ed-ae4d-45f093c98dc32024-12-11WarningsExact identifier
unii: 3K9958V90M
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
ZOEY naturals English Garden HAND SANITIZERETHYL ALCOHOLAbsolutely Natural0c7d0d85-b919-4f47-9888-1ccc91054edf2024-12-11WarningsExact identifier
unii: 3K9958V90M
Zoey Naturals Lemon Squeeze Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.c119069c-092e-49ca-8f89-11fb75c768402024-12-11WarningsExact identifier
unii: 3K9958V90M
MELLOW HAND SANITIZER ALOEETHYL ALCOHOLL.e.d. Cosmetics, Inc.4377ba5e-21f6-407e-9b8c-25e3c6321a5b2024-12-10WarningsExact identifier
unii: 3K9958V90M
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
CVS Hand SanitizerALCOHOLCVSb5faeb31-67c7-2000-e053-2995a90a14092024-12-10WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC29003279-8f27-bcdc-e063-6394a90aa6392024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665461
unii: 4EVE5946BQ
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.4065c34c-d1ca-49bd-9fba-dfa21011592f2024-12-10WarningsExact identifier
unii: 3K9958V90M
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.ec37da5a-8ef7-474b-a5ec-b5edcee03f9d2024-12-10WarningsExact identifier
unii: 3K9958V90M
CSI E3 Hand SanitizerALCOHOLCentral Solutions Incaa07bb62-ef07-99e4-e053-2995a90ae4a82024-12-09WarningsExact identifier
unii: 3K9958V90M
DermaCen Instant Hand SanitizerALCOHOLCentral Solutions Inc36783d30-a222-40fe-a5ea-61a2842a34c92024-12-09WarningsExact identifier
unii: 3K9958V90M
DermaCen Instant Hand Sanitizer with AloeALCOHOLCentral Solutions Incdc6191ae-841f-48b6-b454-72d8d43fdcce2024-12-09WarningsExact identifier
unii: 3K9958V90M
DERMACEN FOAMING INSTANT HAND SANITIZER WITH ALOEALCOHOLCentral Solutions Incd56b9930-b8b0-ad72-e053-2a95a90af5902024-12-09WarningsExact identifier
unii: 3K9958V90M
Guard 2U Hand SanitizerGUARD 2U HAND SANITIZERAmerican Industries, Inc.f41cf3f4-6c6e-7354-e053-2a95a90affcc2024-12-08WarningsExact identifier
unii: 3K9958V90M
San-A-GelSAN-A-GELMisco Industrial, LLCdeac5e37-e1a0-5b4b-e053-2a95a90a9d5b2024-12-08WarningsExact identifier
unii: 3K9958V90M
ApplauseINSTANT HAND SANITIZERQuestSpecialty Corporation774657f1-5c39-2fed-e053-2991aa0a90642024-12-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERFehr Bros. Industries Inceac3f46a-1b61-c4b2-e053-2995a90ae7022024-12-08WarningsExact identifier
unii: 3K9958V90M
SaniTex 60SANITEX 60Solutex, Inc.d57827ec-f724-5081-e053-2a95a90adaaf2024-12-08WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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