FDA.reportPublic FDA data

NDC 68083-134-01 - 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
68083-134
Requested NDC
68083-134-01
Package NDCs from labels
68083-134-01, 68083-134-10
Manufacturer
Gland Pharma Limited
Effective date
2024-09-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ketorolac tromethamine - Gland Pharma LimitedGland Pharma Limited2024-09-20Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-134-01ketorolac tromethamine2 mL in 1 VIALINJECTION, SOLUTION215
68083-134-10ketorolac tromethamine10 in 1 CARTONINJECTION, SOLUTION1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-134KETOROLAC TROMETHAMINE INJECTION, SOLUTION [GLAND PHARMA LIMITED]15Current NDC, Legacy NDC, 2 package rows20240921_5abd4389-4fb2-408b-a27e-cf64b6a921f1.zip

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 2 of 192 · 3,825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsExact identifier
unii: 3K9958V90M
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5aaaf5a5-d43f-cf23-e063-6394a90a72ef2026-09-04WarningsExact identifier
unii: 3K9958V90M
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5aaaff8f-5f6b-d575-e063-6394a90a1edc2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight SmoresALCOHOLChurch & Dwight Co., Inc.5aab0ca1-b3c4-964f-e063-6294a90a263f2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry FizzALCOHOLChurch & Dwight Co., Inc.5aab1faa-d884-1a55-e063-6394a90ad6e22026-09-04WarningsExact identifier
unii: 3K9958V90M
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed3796ee-3078-e850-e053-2a95a90a318a2026-09-03WarningsExact identifier
unii: 3K9958V90M
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed63bd55-941f-9785-e053-2995a90a59522026-09-03WarningsExact identifier
unii: 3K9958V90M
ketorolac tromethamineKETOROLAC TROMETHAMINESportpharm LLC2a23b0fa-803c-4abb-b588-12cfe83326a92026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204216
rxcui: 1665459
unii: 4EVE5946BQ
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
biom Sanitizing Alcohol Wipes - Eucalyptus ChillALCOHOLBiom Innovations Inc23a89b5b-ee5f-4480-e063-6394a90a03b42026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc5a8186f8-2f47-e57c-e063-6394a90a723a2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Aloe YouALCOHOLChurch & Dwight Co., Inc.5a83e963-6a61-fa59-e063-6394a90ade6c2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5a83fc8f-31db-fd2a-e063-6294a90a8c432026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Blue SandalwoodALCOHOLChurch & Dwight Co., Inc.5a840981-765b-07f1-e063-6294a90ac6a32026-09-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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