Ketorolac Tromethamine

Product NDC
70518-3369
11-digit product format
705183369
Labeler code
70518
Product ID
70518-3369_e559ac1f-eceb-98ef-e053-2995a90ae847
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
REMEDYREPACK INC.
Application
ANDA075784
Marketing category
ANDA
Marketing start
2022-02-22
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3369DDiscontinued by firm2026-08-17
excluded packagepackage70518-336970518-3369-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-336970518-3369-2DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3369-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3369-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3369-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3369-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3369-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3369-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3369-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3369-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3369-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3369-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3369-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3369-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70518-3369-0IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075784-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11
A075784-002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075784-001AP
A075784-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075784-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2002-01-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075784-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2002-01-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075784-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A075784-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075784-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075784-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075784-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075784-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075784-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075784-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075784-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075784-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075784-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075784-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075784-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075784-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075784-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075784-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075784-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075784-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075784-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075784-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075784-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075784-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075784-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075784-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075784-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075784-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075784-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075784-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075784-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075784-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075784-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075784-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075784-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075784-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075784-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075784-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075784-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075784-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075784-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075784-002AP1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3369-02024-04-25C16284748780-11030e365-6660-111a-e063-dadaa90a10e2Ketorolac Tromethamine Injection, USP
70518-3369-02024-01-30C16284748780-11030e365-6660-111a-e063-dadaa90a10e2Ketorolac Tromethamine Injection, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3369KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.]5Legacy NDC20241004_093e7b41-d50d-44f7-9594-3f9acdaf0960.zip

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirste46ebc7f-584e-e2b7-e053-2995a90ad17b2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst54dec321-b4c9-f0d6-e063-6294a90ae2312026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf335a030-ffa8-4f42-8166-2f06e036b40d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC63b73913-246d-4e5b-bdc9-c202980d87772025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC6758cb38-dec8-468f-94e2-613772e39b9a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLCd1920335-8e45-4960-b6e9-e6f1f9e6820c2024-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC9e3ddc51-b572-8fe9-e053-2995a90a2f2a2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLC950b7295-3f68-4027-ac2b-2f7d0f5f8ef92022-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLCccf905ca-e164-4779-9485-2d139c821bad2022-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075784
application number: ANDA075784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3369-07051833690025 VIAL, SINGLE-USE in 1 TRAY (70518-3369-0) > 1 mL in 1 VIAL, SINGLE-USE (70518-3369-1) 2022-02-220000-00-00NoNoCurrent