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 67 of 188 · 3,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care CHAMPAGNE TOAST HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.92453675-7775-4dd4-b37d-28327c211cf32026-01-09WarningsExact identifier
unii: 3K9958V90M
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEGLENMARK PHARMACEUTICALS INC., USAce992bee-a9f5-48bd-a00e-513f590d69f22026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Psorinum Combination 9237PSORINUM COMBINATIONProfessional Complementary Health Formulas8b2a133d-9681-4091-a6d1-4ecc4583626b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Ketorocaine LM KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.35ffe071-8bc1-4c88-8c85-645847acf1692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665461
Ketorocaine L KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.ee0d396c-5caa-4a1a-9865-1a742d9d8d682026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665461
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINENephron Pharmaceuticals Corporationae6c60c0-e88a-45b2-e053-2995a90ac62f2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1665459
unii: 4EVE5946BQ
Instant Hand Sanitizer UnscentedALCOHOLHu-Friedy Mfg. Co., Inc.1811a5d8-8a08-4a40-88e2-f86e822e610d2026-01-08WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer CitrusALCOHOLSoapbox Soaps LLC3a08a336-aac1-4b6e-acc5-799330e4dcfc2026-01-08WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLNew World Imports, Inc.29d8c137-9a55-4e37-bdec-bdf48a7d39ed2026-01-08WarningsExact identifier
unii: 3K9958V90M
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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