Ketorolac Tromethamine

Product NDC
71872-7188
11-digit product format
718727188
Labeler code
71872
Product ID
71872-7188_9e3ef54f-1f47-cf43-e053-2995a90afab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA074802
Marketing category
ANDA
Marketing start
2015-10-30
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
60 mg/2mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71872-7188IInactivated by FDA2026-08-03
excluded packagepackage71872-718871872-7188-1IInactivated by FDA2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71872-7188-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71872-7188-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71872-7188-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71872-7188-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71872-7188-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71872-7188-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71872-7188-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71872-7188-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71872-7188-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71872-7188-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71872-7188-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71872-7188-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71872-7188-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71872-7188-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71872-7188-11332a3947898…d4bfe170f9cd…

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

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
A074802-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05
A074802-002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074802-001AP
A074802-002AP

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074802-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074802-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074802-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074802-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074802-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074802-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074802-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074802-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074802-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074802-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074802-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074802-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074802-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074802-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074802-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074802-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074802-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074802-002AP1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71872-7188-12023-01-30C16284748780-1f386c649-fa31-0266-e053-dadaa90a7c1aKetorolac Tromethamine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7188-1Ketorolac Tromethamine2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
71872-7188-1Ketorolac Tromethamine1 in 1 BAGINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7188KETOROLAC TROMETHAMINE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Legacy NDC, 2 package rows20200211_9e3ef80d-f2ce-dd5a-e053-2995a90af4be.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.8accbb78-fc64-45d5-69b0-35c23a1d2a2e2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCdd489c86-08c0-4457-86f3-c4f36a70276c2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf0cd5dfa-7eba-449f-a54a-a5155024a77e2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst3d746288-681a-5232-e063-6394a90afabd2025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.004588ba-e109-4a53-9c9d-a42dea9bb8482022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst76446045-3cca-0206-e053-2a91aa0a24402020-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN9e3ef80d-f2ce-dd5a-e053-2995a90af4be1
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD9e3ef80d-f2ce-dd5a-e053-2995a90af4be1
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY9e3ef80d-f2ce-dd5a-e053-2995a90af4be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7188-1718727188011 VIAL, SINGLE-DOSE in 1 BAG (71872-7188-1) > 2 mL in 1 VIAL, SINGLE-DOSE2019-12-170000-00-00NoNoCurrent