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 5 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx of Tennessee, LLC2cf7516b-ac86-ca72-e063-6394a90a43392025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECaplin Steriles Limited4ba4a228-75d6-4a77-bf34-0381b2a896022025-01-23Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEDirect Rxd9a589b4-bd32-0e45-e053-2a95a90ae67d2025-01-21Exact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx Pharmacy of Tennessee, LLCc1717245-cef3-b3d7-e053-2a95a90a1ac52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074754
ndc (package): 80425-0139-1
ndc (package): 80425-0139-2
ndc (package): 80425-0139-3
ndc (product): 80425-0139
ndc11 (package): 80425013901
rxcui: 834022
spl id: 2a99c981-daeb-71e5-e063-6294a90a5c1d
spl set id: c1717245-cef3-b3d7-e053-2a95a90a1ac5
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx Pharmacy of Tennessee, LLCf4e7f1c8-e458-0860-e053-2a95a90a1bf02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINETeva Pharmaceuticals USA, Inc.688f5dec-a6db-43c6-a1f8-5df99d08d3952024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074754
ndc (product): 0093-0314
rxcui: 834022
spl id: 06cd0a02-e137-4ae7-9f76-a416efe1f191
spl set id: 688f5dec-a6db-43c6-a1f8-5df99d08d395
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC2900e69d-29ec-210a-e063-6294a90a50082024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC29003279-8f27-bcdc-e063-6394a90aa6392024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Toronova SUIKKETOROLAC TROMETHAMINEAdvanced Rx of Tennessee, LLC275f9131-5915-a585-e063-6294a90ab0fc2024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
SprixKETOROLAC TROMETHAMINEZyla Life Sciences US LLC97005a1c-167e-4676-bae7-e49b38c36f9e2024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions6fa20b41-f860-4fea-b1fb-ab6d3fa34a902024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECivica, Inc.1e8ddf13-c513-4e16-a91a-9d55726d90712024-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepack8a495869-cbf7-4164-b3b2-6d4215edae6a2024-11-04Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions18981677-8049-4864-b31c-96a299e3194d2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINECamber Pharmaceuticals, Inc.478aff0b-29fd-43b2-a701-5236b8f8e3df2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINECaplin Steriles Limited588b4804-4ac5-4b96-947e-354029ea4df92024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEBaxter Healthcare Corporation4b58836d-9d58-4539-9691-9e11c505ef2a2024-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEFOSUN PHARMA USA INC1aae6a4d-0909-4672-aa26-e3f2d8c4d4132024-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEGland Pharma Limited5abd4389-4fb2-408b-a27e-cf64b6a921f12024-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.2266e650-a0e9-027d-e063-6394a90a795d2024-09-18Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ

Reported adverse events (FAERS/openFDA)#

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