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 85 of 188 · 3,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WhiskCare 375ALCOHOLWhisk Products, Inc.63c61968-73d7-4d31-9604-e56748b990fa2025-11-11WarningsExact identifier
unii: 3K9958V90M
Walgreens Hand Sanitizer Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.435ca082-0b6b-c55e-e063-6294a90af56e2025-11-11WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d514e-204a-118b-e063-6294a90aa8a62025-11-11WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Spider-manALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d939c-9bef-bf86-e063-6394a90a41422025-11-11WarningsExact identifier
unii: 3K9958V90M
SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.af6aebad-ef03-4d19-9a40-18e5a278b8122025-11-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Smart Care SPIDER-MAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.58cec7e5-65f9-4b39-a1a0-453fb293fe252025-11-11WarningsExact identifier
unii: 3K9958V90M
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC27dbf0bf-c273-2108-e063-6394a90a0a092025-11-10WarningsExact identifier
unii: 451W47IQ8X
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
unii: 3K9958V90M
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
unii: 451W47IQ8X
Surface x Cutie Pals Hand Sanitizer Cherry ColaALCOHOLLongway Technology(Guangzhou)Co., Ltd.635f1363-cd21-4d3c-8326-62c39fbd12ab2025-11-07WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Hand SanitizerALCOHOLGFA Production(Xiamen) Co.,Ltd0aaee809-d251-6119-e063-6294a90aee7a2025-11-07WarningsExact identifier
unii: 3K9958V90M
SODIUM CHLORIDESODIUM CHLORIDEHenry Schein, Inc.2e81ffca-05c6-4fa0-8911-4b3cbfa713512025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Smart Care VANILLA VERDANT HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.ccf2f735-19ca-47b0-9343-0353a556dc112025-11-07WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizing Wipes Alcohol FormulaALCOHOLGOJO Industries, Inc.390859de-2d8d-40f8-a0fc-05f7644e266c2025-11-06WarningsExact identifier
unii: 3K9958V90M
MedlineETHYL ALCOHOLMedline Industries, LP11fcc7e7-dfae-ee7d-e063-6294a90a3b312025-11-06WarningsExact identifier
unii: 3K9958V90M
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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