Ketorolac Tromethamine

Product NDC
80425-0139
11-digit product format
804250139
Labeler code
80425
Product ID
80425-0139_2a99c981-daeb-71e5-e063-6294a90a5c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074754-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074754-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074754-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074754-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074754-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074754-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074754-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074754-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074754-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074754-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074754-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074754-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074754-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074754-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074754-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074754-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074754-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074754-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074754-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074754-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074754-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074754-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074754-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074754-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074754-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074754-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074754-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074754-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074754-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074754-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074754-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074754-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074754-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074754-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074754-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074754-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074754-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074754-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074754-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074754-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074754-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074754-001AB1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.f47d4365-40a8-445b-99cd-49edad6a8ffc2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC0749f61d-12e6-4280-8f41-bd4df81e7ae62026-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENorthwind Health Company, LLCd17ed469-677b-4a2e-96a9-5cfd0f50ecd92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAmerican Health Packaging48244614-53ec-47e6-ad48-50814bdcceb72025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEPD-Rx Pharmaceuticals, Inc.add10ccd-c205-4512-9619-253290fa11522025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions9fdba2e6-969f-4624-b08b-a42f99e4eff92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx Pharmacy of Tennessee, LLCc1717245-cef3-b3d7-e053-2a95a90a1ac52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
ndc (product): 80425-0139
Ketorolac TromethamineKETOROLAC TROMETHAMINETeva Pharmaceuticals USA, Inc.688f5dec-a6db-43c6-a1f8-5df99d08d3952024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.415a5393-296f-30e3-e054-00144ff8d46c2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.46dc8f62-e754-50e3-e054-00144ff8d46c2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackf713500a-20b8-8e20-c4cc-9568051703352023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.94c7c57a-fd1e-41ab-bc39-9a538f6011d12023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LPf5170993-81a9-4eb7-95ac-60697a5ee1d72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4EVE5946BQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834022Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1717245-cef3-b3d7-e053-2a95a90a1ac5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNc1717245-cef3-b3d7-e053-2a95a90a1ac55
834022ketorolac tromethamine 10 MG Oral TabletSCDc1717245-cef3-b3d7-e053-2a95a90a1ac55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0139-18042501390130 TABLET, FILM COATED in 1 BOTTLE (80425-0139-1) 1998-06-170000-00-00NoNoCurrent
80425-0139-2804250139029 TABLET, FILM COATED in 1 BOTTLE (80425-0139-2) 1998-06-170000-00-00NoNoCurrent
80425-0139-38042501390320 TABLET, FILM COATED in 1 BOTTLE (80425-0139-3) 1998-06-170000-00-00NoNoCurrent