FDA.reportPublic FDA data

NDC 65145-147-01 - 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
65145-147
Requested NDC
65145-147-01
Package NDCs from labels
65145-147-01, 65145-147-25
Manufacturer
Caplin Steriles Limited
Effective date
2024-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KETOROLAC TROMETHAMINE - Caplin Steriles LimitedCaplin Steriles Limited2024-10-04Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-147-01KETOROLAC TROMETHAMINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23
65145-147-25KETOROLAC TROMETHAMINE25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-147KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]3Current NDC, 2 package rows20241006_588b4804-4ac5-4b96-947e-354029ea4df9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-147-01ML - Milliliter65145-147db0cdaff-346d-4f35-89f2-8b01cb860c0112024-10-04
65145-147-25ML - Milliliter65145-147d8865764-dde4-4e03-8642-8f47dd54fe7e12024-10-04

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 81 of 195 · 3,886 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLC1a8cb031-5608-400f-b924-feb6bbd17fa12025-12-09WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINESOLA Pharmaceuticals, LLC2301a6a2-b88a-4c0d-bb6c-ad4a8af7da392025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217789
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINESOLA Pharmaceuticals, LLCb08a46f3-36c9-405d-a963-9739a5c87f9c2025-12-08Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
unii: 3K9958V90M
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
unii: 3K9958V90M
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
unii: 3K9958V90M
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
Ketorolac TromethamineKETOROLAC TROMETHAMINEChartwell RX, LLC3855f527-fd6c-4f24-a4b4-cd47eec1193d2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 451W47IQ8X
Mrs. Meyers Clean Day Hand Sanitizer Basil ScentALCOHOLThe Caldrea Companyd263d012-997c-4029-b771-e8f346da59882025-12-04WarningsExact identifier
unii: 3K9958V90M
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen, Pink Kiwi Splash ScentedALCOHOLFourstar Group USA, Inc.f8b8b820-467b-49eb-8bec-16d39ba32e962025-12-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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