FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
69315-322
11-digit product format
693150322
Labeler code
69315
Product ID
69315-322_11be552b-2427-4cd7-a81d-f0ae5063d3f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Leading Pharma, LLC
Application
ANDA218204
Marketing category
ANDA
Marketing start
2024-06-01
Substance
KETOROLAC TROMETHAMINE
Active strength
5 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218204-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218204-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-268072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218204-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2024-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218204-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A218204-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218204-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218204-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218204-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218204-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218204-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218204-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218204-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218204-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218204-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218204-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218204-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218204-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218204-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218204-001AT18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218204-001AT1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE5 mg/mL

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
860107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c34b69c6-5cdf-41f6-8652-33bd8e9c6c70Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-322-03Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS11
69315-322-03Ketorolac Tromethamine3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS31
69315-322-05Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51
69315-322-05Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS11
69315-322-10Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS11
69315-322-10Ketorolac Tromethamine10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-322-05ML - Milliliter69315-32284a1aec3-fd5f-430c-a623-c6ee763ae3cc12024-07-12
69315-322-10ML - Milliliter69315-3223fce93b1-cb9a-4528-83ef-e24b082e7bd612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-322KETOROLAC TROMETHAMINE SOLUTION/ DROPS [LEADING PHARMA, LLC]1Current NDC, 6 package rows20240601_c34b69c6-5cdf-41f6-8652-33bd8e9c6c70.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug59d86768-6214-8389-e063-6394a90a0a3d2026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug53cb9528-7640-1fd4-e063-6294a90a74ad2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug49ade79d-4d23-6611-e063-6294a90adfaa2026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
Ketorolac TromethamineKETOROLAC TROMETHAMINESOLA Pharmaceuticals, LLCb08a46f3-36c9-405d-a963-9739a5c87f9c2025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
Ketorolac TromethamineKETOROLAC TROMETHAMINECaplin Steriles Limited4ba4a228-75d6-4a77-bf34-0381b2a896022025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.2266e650-a0e9-027d-e063-6394a90a795d2024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
Ketorolac TromethamineKETOROLAC TROMETHAMINELeading Pharma, LLCc34b69c6-5cdf-41f6-8652-33bd8e9c6c702024-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218204
application number: ANDA218204
ndc (product): 69315-322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN2266e650-a0e9-027d-e063-6394a90a795d1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN249b0f15-9c13-90e2-e063-6394a90a1fd51
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNc34b69c6-5cdf-41f6-8652-33bd8e9c6c701
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN249b0f15-9c13-90e2-e063-6394a90a1fd51
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD2266e650-a0e9-027d-e063-6394a90a795d1
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD249b0f15-9c13-90e2-e063-6394a90a1fd51
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDc34b69c6-5cdf-41f6-8652-33bd8e9c6c701
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD249b0f15-9c13-90e2-e063-6394a90a1fd51
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY2266e650-a0e9-027d-e063-6394a90a795d1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY249b0f15-9c13-90e2-e063-6394a90a1fd51
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYc34b69c6-5cdf-41f6-8652-33bd8e9c6c701
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY249b0f15-9c13-90e2-e063-6394a90a1fd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69315-322-03693150322031 BOTTLE, DROPPER in 1 CARTON (69315-322-03) / 3 mL in 1 BOTTLE, DROPPER2024-06-01NoNoCurrent
69315-322-05693150322051 BOTTLE, DROPPER in 1 CARTON (69315-322-05) / 5 mL in 1 BOTTLE, DROPPER2024-06-01NoNoCurrent
69315-322-10693150322101 BOTTLE, DROPPER in 1 CARTON (69315-322-10) / 10 mL in 1 BOTTLE, DROPPER2024-06-01NoNoCurrent