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 2 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf335a030-ffa8-4f42-8166-2f06e036b40d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEInjecta Medcial LLC521b3d09-df08-fcae-e063-6294a90a65452026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEPreferred Pharmaceuticals Inc.92546f61-bbd8-430a-ac92-89dfbe8e2f292026-05-15Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINERedpharm Drug51d443f8-716d-af3a-e063-6394a90a56a32026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf0cd5dfa-7eba-449f-a54a-a5155024a77e2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC3efb4f4e-b849-3bb5-e063-6394a90a53052026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEDirect_rx22de8e1c-5e68-fd78-e063-6394a90ad40b2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals,Inc.c2290fd1-2985-1275-e053-2995a90ad5fa2026-03-13Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEDirect_Rx19fffe42-a02d-26eb-e063-6294a90aea5a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEAurobindo Pharma Limited007a4da5-d794-416c-94b3-6ee9e7842c522026-02-26Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEMajor Pharmaceuticals48245718-a2df-4938-8d06-3b8abf34181e2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepack23e7b5f7-ea0d-468d-9d13-a95f9bf605c62026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEBaxter Healthcare Corporation30a3ca20-8f98-478c-8a6b-aa617f0a17a32026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.43d07956-90ba-4e96-b265-aec03eced19b2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECivica, Inc.32198544-4a46-495c-ab65-0836dcbc2c492026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug49ade79d-4d23-6611-e063-6294a90adfaa2026-01-31Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Toronova II SUIKKETOROLAC TROMETHAMINEAdvanced Rx of Tennessee, LLC49dd153c-10e8-505b-e063-6394a90a595f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEGLENMARK PHARMACEUTICALS INC., USAce992bee-a9f5-48bd-a00e-513f590d69f22026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINENephron Pharmaceuticals Corporationae6c60c0-e88a-45b2-e053-2995a90ac62f2026-01-08Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Toronova SUIKKETOROLAC TROMETHAMINEAsclemed USA, Inc.e0ed6947-5520-403b-bc0e-1caa95ab33022026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ

Reported adverse events (FAERS/openFDA)#

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