FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
60505-1003
11-digit product format
605051003
Labeler code
60505
Product ID
60505-1003_fb740a51-5459-3c22-949d-7e4c9142fe84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA076109
Marketing category
ANDA
Marketing start
2009-12-07
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

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 Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product 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
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-1003-1Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS513
60505-1003-1Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS113
60505-1003-2Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS113
60505-1003-2Ketorolac Tromethamine10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1003-1ML - Milliliter60505-10039242ed86-ca0a-4b36-8ca2-eba63b8be90312012-07-24
60505-1003-2ML - Milliliter60505-1003b5119ae4-e5cf-48d3-8cc5-8eeb4fe10e6712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
KetorolacACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
OCTOXYNOL-40INACTIVE INGREDIENT9T1C662FKSKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1003KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]11Current NDC, Legacy NDC, 4 package rows20240927_d9a186ba-74a9-b6d4-1109-1e045ba1763e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNd9a186ba-74a9-b6d4-1109-1e045ba1763e13
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDd9a186ba-74a9-b6d4-1109-1e045ba1763e13
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYd9a186ba-74a9-b6d4-1109-1e045ba1763e13
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN76f4b8d2-3fe7-4555-92e8-7d63a68633b610
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD76f4b8d2-3fe7-4555-92e8-7d63a68633b610
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY76f4b8d2-3fe7-4555-92e8-7d63a68633b610
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN2f27e304-7a96-47b6-8ef1-8a649c25abcf4
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD2f27e304-7a96-47b6-8ef1-8a649c25abcf4
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY2f27e304-7a96-47b6-8ef1-8a649c25abcf4
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN3b3cc67c-e1ff-3a0a-e063-6394a90adb9a1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN1c5659e6-78f2-2816-e063-6294a90a87ed1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN7d62291a-6193-458a-e053-2a91aa0a1af71
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN9624d675-0b7f-8630-e053-2a95a90a2fd01
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD3b3cc67c-e1ff-3a0a-e063-6394a90adb9a1
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD7d62291a-6193-458a-e053-2a91aa0a1af71
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD9624d675-0b7f-8630-e053-2a95a90a2fd01
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD1c5659e6-78f2-2816-e063-6294a90a87ed1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY3b3cc67c-e1ff-3a0a-e063-6394a90adb9a1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY7d62291a-6193-458a-e053-2a91aa0a1af71
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY9624d675-0b7f-8630-e053-2a95a90a2fd01
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY1c5659e6-78f2-2816-e063-6294a90a87ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-1003-1605051003011 BOTTLE, DROPPER in 1 CARTON (60505-1003-1) / 5 mL in 1 BOTTLE, DROPPER2009-12-070000-00-00NoNoCurrent
60505-1003-2605051003021 BOTTLE, DROPPER in 1 CARTON (60505-1003-2) / 10 mL in 1 BOTTLE, DROPPER2009-12-070000-00-00NoNoCurrent