FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
65145-138
11-digit product format
651450138
Labeler code
65145
Product ID
65145-138_2fc3da7c-dbd4-4de7-a55f-40d94991e6d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Caplin Steriles Limited
Application
ANDA218204
Marketing category
ANDA
Marketing start
2025-01-23
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-138-01Ketorolac Tromethamine3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS32
65145-138-01Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-138KETOROLAC TROMETHAMINE SOLUTION/ DROPS [CAPLIN STERILES LIMITED]2Current NDC, 2 package rows20250124_4ba4a228-75d6-4a77-bf34-0381b2a89602.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN4ba4a228-75d6-4a77-bf34-0381b2a896022
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD4ba4a228-75d6-4a77-bf34-0381b2a896022
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY4ba4a228-75d6-4a77-bf34-0381b2a896022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65145-138-01651450138011 BOTTLE, DROPPER in 1 CARTON (65145-138-01) / 3 mL in 1 BOTTLE, DROPPER2025-01-23NoNoCurrent