NDC 80425-0267-03 - 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
80425-0267
Requested NDC
80425-0267-03
Package NDCs from labels
80425-0267-1, 80425-0267-2, 80425-0267-3, 80425-0267-4, 80425-0267-5, 80425-0267-03
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
80425-0267-1Ketorolac Tromethamine9 in 1 BOTTLETABLET, FILM COATED93
80425-0267-2Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED203
80425-0267-3Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED303
80425-0267-4Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED603
80425-0267-5Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0267KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 5 package rows20250102_f4e7f1c8-e458-0860-e053-2a95a90a1bf0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0267-1EA - Each80425-02677f333244-4aa6-487e-9bfa-3c425d655b2f12023-04-07
80425-0267-2EA - Each80425-026744667709-05c6-4da2-bdda-fffbed00dfa112023-04-07
80425-0267-3EA - Each80425-02670b79c085-7336-4a3b-aecf-f92f2256cbd012023-04-07
80425-0267-4EA - Each80425-026789140c3e-8295-4419-960c-9f33244ecd3f12023-04-07
80425-0267-5EA - Each80425-026758a927a8-9ee5-408c-aa6c-a943444b53e512023-06-06

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 1 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEAmerisyn LLC5734e81e-2471-1314-e063-6294a90ac9fe2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215788
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.8accbb78-fc64-45d5-69b0-35c23a1d2a2e2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEApotex Corp.d9a186ba-74a9-b6d4-1109-1e045ba1763e2026-07-16Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirste46ebc7f-584e-e2b7-e053-2995a90ad17b2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINESt. Mary's Medical Park Pharmacy2d552135-bde5-5fe9-e063-6394a90af4332026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.f47d4365-40a8-445b-99cd-49edad6a8ffc2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst54dec321-b4c9-f0d6-e063-6294a90ae2312026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCdd489c86-08c0-4457-86f3-c4f36a70276c2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEInjecta Medcial LLC515464a7-16c5-2811-e063-6294a90aa4512026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEPreferred Pharmaceuticals Inc.1e7ae5af-76b9-49a9-ba14-52b566929c222026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug53cb9528-7640-1fd4-e063-6294a90a74ad2026-06-09Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.26a1761b-90bf-49c6-9e6a-f293af2296ce2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
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 TROMETHAMINEPreferred Pharmaceuticals Inc.337afb4f-789f-4cac-817a-e4286664a71e2026-05-15Boxed 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