FDA.reportPublic FDA data

ACULAR LS

Product NDC
0023-9277
11-digit product format
000239277
Labeler code
0023
Product ID
0023-9277_15504a86-2bf2-470a-ad3d-99132d07d42d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA021528
Marketing category
NDA
Marketing start
2003-08-19
Substance
KETOROLAC TROMETHAMINE
Active strength
4 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
ACULAR LS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860103, 860105

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
0023-9277-05ACULAR LS5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS517
0023-9277-05ACULAR LS1 in 1 CARTONSOLUTION/ DROPS117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9277-05ML - Milliliter0023-9277bee14956-f377-4e45-bd20-600eb70ed8b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketorolac tromethamineACTIVE INGREDIENT4EVE5946BQACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
ketorolacACTIVE MOIETYYZI5105V0LACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
edetate disodiumINACTIVE INGREDIENT7FLD91C86KACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
hydrochloric acidINACTIVE INGREDIENTQTT17582CBACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
octoxynol-40INACTIVE INGREDIENT9T1C662FKSACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
sodium chlorideINACTIVE INGREDIENT451W47IQ8XACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
sodium hydroxideINACTIVE INGREDIENT55X04QC32IACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6
waterINACTIVE INGREDIENT059QF0KO0RACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9277ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]17Current NDC, Legacy NDC, 2 package rows20240704_4fad0873-f79c-4f07-9fac-5060be6b38fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860105ACULAR LS 0.4 % Ophthalmic SolutionPSN4fad0873-f79c-4f07-9fac-5060be6b38fe17
860103ketorolac tromethamine 0.4 % Ophthalmic SolutionPSN4fad0873-f79c-4f07-9fac-5060be6b38fe17
860105ketorolac tromethamine 4 MG/ML Ophthalmic Solution [Acular]SBD4fad0873-f79c-4f07-9fac-5060be6b38fe17
860103ketorolac tromethamine 4 MG/ML Ophthalmic SolutionSCD4fad0873-f79c-4f07-9fac-5060be6b38fe17
860105Acular 0.4 % Ophthalmic SolutionSY4fad0873-f79c-4f07-9fac-5060be6b38fe17
860105Acular 4 MG/ML Ophthalmic SolutionSY4fad0873-f79c-4f07-9fac-5060be6b38fe17
860105Acular LS 0.4 % Ophthalmic SolutionSY4fad0873-f79c-4f07-9fac-5060be6b38fe17
860105Acular LS 4 MG/ML Ophthalmic SolutionSY4fad0873-f79c-4f07-9fac-5060be6b38fe17
860103ketorolac tromethamine 0.4 % Ophthalmic SolutionSY4fad0873-f79c-4f07-9fac-5060be6b38fe17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-9277-05000239277051 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPER2003-08-190000-00-00NoNoCurrent