FDA.reportPublic FDA data

KETOROLAC TROMETHAMINE

Product NDC
61314-126
11-digit product format
613140126
Labeler code
61314
Product ID
61314-126_2833a9fe-4416-4012-8d2c-c9d5090fd2e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA076583
Marketing category
ANDA
Marketing start
2009-11-05
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
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
61314-126-05KETOROLAC TROMETHAMINE1 in 1 CARTONSOLUTION19
61314-126-05KETOROLAC TROMETHAMINE5 mL in 1 BOTTLESOLUTION59
61314-126-10KETOROLAC TROMETHAMINE1 in 1 CARTONSOLUTION19
61314-126-10KETOROLAC TROMETHAMINE10 mL in 1 BOTTLESOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-126KETOROLAC TROMETHAMINE SOLUTION [SANDOZ INC]8Current NDC, Legacy NDC, 4 package rows20220212_79e29a86-1b44-4d95-8d84-5a2e8f23ddcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNa1ebb51e-4658-4852-bf90-1983a3d4478314
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDa1ebb51e-4658-4852-bf90-1983a3d4478314
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYa1ebb51e-4658-4852-bf90-1983a3d4478314
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN79e29a86-1b44-4d95-8d84-5a2e8f23ddcf9
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD79e29a86-1b44-4d95-8d84-5a2e8f23ddcf9
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY79e29a86-1b44-4d95-8d84-5a2e8f23ddcf9
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNc4598ce4-41fb-4cc9-8102-3a66a9bfa36a4
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDc4598ce4-41fb-4cc9-8102-3a66a9bfa36a4
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYc4598ce4-41fb-4cc9-8102-3a66a9bfa36a4
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNae2e626c-0019-7c4e-e053-2995a90a23be3
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDae2e626c-0019-7c4e-e053-2995a90a23be3
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYae2e626c-0019-7c4e-e053-2995a90a23be3
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNca7a8de8-9185-e89f-e053-2995a90a5e042
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNca7a8de8-9185-e89f-e053-2995a90a5e042
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDca7a8de8-9185-e89f-e053-2995a90a5e042
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDca7a8de8-9185-e89f-e053-2995a90a5e042
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYca7a8de8-9185-e89f-e053-2995a90a5e042
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYca7a8de8-9185-e89f-e053-2995a90a5e042
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN2f2bc309-6da3-4e44-92ce-aff2854bab611
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN1fc22064-3f54-97c7-e063-6294a90abf0e1
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD2f2bc309-6da3-4e44-92ce-aff2854bab611
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD1fc22064-3f54-97c7-e063-6294a90abf0e1
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY2f2bc309-6da3-4e44-92ce-aff2854bab611
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY1fc22064-3f54-97c7-e063-6294a90abf0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-126-05613140126051 BOTTLE in 1 CARTON (61314-126-05) / 5 mL in 1 BOTTLE1 bottle2009-11-050000-00-00NoNoCurrent
61314-126-10613140126101 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLE1 bottle2009-11-050000-00-00NoNoCurrent