FDA.reportPublic FDA data

NDC 80425-0139-01 - 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
80425-0139
Requested NDC
80425-0139-01
Package NDCs from labels
80425-0139-1, 80425-0139-3, 80425-0139-2, 80425-0139-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0139-1Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED305
80425-0139-2Ketorolac Tromethamine9 in 1 BOTTLETABLET, FILM COATED95
80425-0139-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0139KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 3 package rows20250101_c1717245-cef3-b3d7-e053-2a95a90a1ac5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0139-1EA - Each80425-013970add81b-d8f5-4118-b5c1-05bf84165ade12023-06-06
80425-0139-2EA - Each80425-01390b665173-2504-4c55-b5a5-980fa83937b712023-06-06
80425-0139-3EA - Each80425-0139fcf73ba8-2e41-4714-89c3-f0dc2d794b1e12023-06-06

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 7 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINELeading Pharma, LLC04df9620-6dcb-494a-83e2-6d28036be9742024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEA-S Medication Solutionsa1ebb51e-4658-4852-bf90-1983a3d447832023-12-10Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackf713500a-20b8-8e20-c4cc-9568051703352023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074754
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepack9e5fde54-2206-4072-afb8-4d06a8d314b12023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutionse0065781-ea33-4662-a8b1-c936e937ac9f2023-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.94c7c57a-fd1e-41ab-bc39-9a538f6011d12023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074754
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLC3d88cbe6-5230-47aa-80af-0c41283d1f002023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC9e3ddc51-b572-8fe9-e053-2995a90a2f2a2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac tromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLCada639d4-babb-2ad0-e053-2a95a90afce72023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac tromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLCe17f583d-8bd4-3ed0-e053-2a95a90a90902023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutionsb88e562d-226b-4200-afa5-034e628c660f2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLC950b7295-3f68-4027-ac2b-2f7d0f5f8ef92022-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEATNAHS PHARMA US LIMITED57ea681c-392e-4f41-a374-91ed204731612022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LP2f27e304-7a96-47b6-8ef1-8a649c25abcf2022-11-01Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECamber Pharmaceuticals, Inc.e1fb8753-4695-4cb2-83d7-15d79fbaeeb22022-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.004588ba-e109-4a53-9c9d-a42dea9bb8482022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLCccf905ca-e164-4779-9485-2d139c821bad2022-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac tromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.ee44c322-4b4b-4397-a1a5-e5b3c3c5a0532022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEProficient Rx LPc4598ce4-41fb-4cc9-8102-3a66a9bfa36a2022-08-01Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LPf5170993-81a9-4eb7-95ac-60697a5ee1d72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074754
rxcui: 834022
unii: 4EVE5946BQ

Reported adverse events (FAERS/openFDA)#

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