FDA.reportPublic FDA data

NDC 68083-133-01 - 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
68083-133
Requested NDC
68083-133-01
Package NDCs from labels
68083-133-01, 68083-133-10
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
68083-133-01ketorolac tromethamine1 mL in 1 VIALINJECTION, SOLUTION115
68083-133-10ketorolac tromethamine10 in 1 CARTONINJECTION, SOLUTION1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-133KETOROLAC 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 95 of 188 · 3,747 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEOnesource Specialty Pharma Limited4596483b-990b-eaa4-e063-6394a90ac08f2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEOnesource Specialty Pharma Limited45966992-5af6-bf10-e063-6294a90af25b2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEMicro Labs Limited631c2c31-cd4f-4a17-85c6-be96746a753e2025-09-29Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
PURELL Hand Sanitizer SP Berry and CitrusALCOHOLGOJO Industries, Inc.3fb7bccb-a699-a10d-e063-6294a90a49bc2025-09-26WarningsExact identifier
unii: 3K9958V90M
Fresh Feels Hand SanitizerFRESH FEELS HAND SANITIZERZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3e36e2c4-fe4d-d517-e063-6394a90ac4be2025-09-25WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(CHERRY)HAND SANITIZER(CHERRY)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6cc842-8b54-9a27-e063-6294a90a1dd52025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(PEACH)HAND SANITIZER(PEACH)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6bf6be-5328-8151-e063-6294a90a82112025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(COCONUT)HAND SANITIZER(COCONUT)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6ca090-98d9-4650-e063-6294a90a35c02025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(MANGO)HAND SANITIZER(MANGO)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6c79b9-d4b1-bbaf-e063-6394a90a11002025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Matcha MoodALCOHOLScent Theory Products LLC3f8fc09d-863d-0c13-e063-6394a90a49682025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Ocean MistALCOHOLScent Theory Products LLC3f8fd236-e413-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sunrise CitrusALCOHOLScent Theory Products LLC3f8fd236-e415-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Velvet VanillaALCOHOLScent Theory Products LLC3f8fdb54-2e2c-2cab-e063-6394a90a1f092025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sun-Kissed MelonALCOHOLScent Theory Products LLC3f8fe3c4-1373-b45a-e063-6294a90ae05b2025-09-24WarningsExact identifier
unii: 3K9958V90M
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
unii: 3K9958V90M
Smart Care WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b2025-09-24WarningsExact identifier
unii: 3K9958V90M
First Aid Direct Hand SanitizerHAND SANITIZERCintas Corporationdad0fc5d-4a48-4db1-b423-558c2958750c2025-09-24WarningsExact identifier
unii: 3K9958V90M
Tendersant Hand SanitizerALCOHOLGeri-Gentle Corporationb09d568a-4c9d-5804-e053-2a95a90ab8ea2025-09-23WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA SUGAR HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bad645e8-4f99-4629-9259-9ae856e16d302025-09-22WarningsExact identifier
unii: 3K9958V90M
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e04b42dd-68ce-44d9-be1b-c4a5d9a646612025-09-19WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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