Ketorolac Tromethamine

Product NDC
45865-613
11-digit product format
458650613
Labeler code
45865
Product ID
45865-613_7d62291a-6194-458a-e053-2a91aa0a1af7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Medsource Pharmaceuticals
Application
ANDA076109
Marketing category
ANDA
Marketing start
2009-12-07
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
5 mg/mL
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
2020-12-31
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 productproduct45865-613IInactivated by FDA2026-08-17
excluded packagepackage45865-61345865-613-01IInactivated by FDA2026-08-17

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 · 18 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-613-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-613-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-613-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-613-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-613-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-613-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-613-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-613-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-613-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

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
A076109-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076109-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-053f01610625f2…
2019-09-15 20:21 UTC2019-09A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076109-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076109-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076109-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076109-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076109-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076109-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076109-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076109-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076109-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076109-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076109-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076109-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076109-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076109-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076109-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076109-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076109-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076109-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076109-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076109-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076109-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076109-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076109-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A076109-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076109-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076109-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076109-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A076109-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076109-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076109-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076109-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076109-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076109-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076109-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076109-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076109-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076109-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076109-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076109-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076109-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076109-001AT1e64feba35796…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-613-01Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51
45865-613-01Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-613KETOROLAC TROMETHAMINE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181220_7d62291a-6193-458a-e053-2a91aa0a1af7.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEApotex Corp.d9a186ba-74a9-b6d4-1109-1e045ba1763e2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076109
application number: ANDA076109
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.3b3cc67c-e1ff-3a0a-e063-6394a90adb9a2025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076109
application number: ANDA076109
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LP2f27e304-7a96-47b6-8ef1-8a649c25abcf2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076109
application number: ANDA076109

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN7d62291a-6193-458a-e053-2a91aa0a1af71
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD7d62291a-6193-458a-e053-2a91aa0a1af71
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY7d62291a-6193-458a-e053-2a91aa0a1af71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-613-01458650613011 BOTTLE, DROPPER in 1 CARTON (45865-613-01) > 5 mL in 1 BOTTLE, DROPPER2018-06-010000-00-00NoNoCurrent