KETOROLAC TROMETHAMINE

Product NDC
72189-335
11-digit product format
721890335
Labeler code
72189
Product ID
72189-335_2c3d8ffc-3ef5-cfa1-e063-6394a90a868e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Direct Rx
Application
ANDA203410
Marketing category
ANDA
Marketing start
2022-03-07
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
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
72189-335-05KETOROLAC TROMETHAMINE5 mL in 1 BOTTLESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-335KETOROLAC TROMETHAMINE SOLUTION [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250122_d9a589b4-bd32-0e45-e053-2a95a90ae67d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNd9a589b4-bd32-0e45-e053-2a95a90ae67d2
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDd9a589b4-bd32-0e45-e053-2a95a90ae67d2
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYd9a589b4-bd32-0e45-e053-2a95a90ae67d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-335-05721890335055 mL in 1 BOTTLE (72189-335-05) 5 ml2022-03-070000-00-00NoNoCurrent