FDA.reportPublic FDA data

ACUVAIL

Product NDC
0023-3507
11-digit product format
000233507
Labeler code
0023
Product ID
0023-3507_ee96bc53-04b7-4ea7-8fab-835ed3648561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA022427
Marketing category
NDA
Marketing start
2009-08-01
Substance
KETOROLAC TROMETHAMINE
Active strength
4.5 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
ACUVAIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE4.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui858364, 858366

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
0023-3507-05ACUVAIL0.4 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.419
0023-3507-05ACUVAIL5 in 1 CARTONSOLUTION/ DROPS519
0023-3507-30ACUVAIL30 in 1 CARTONSOLUTION/ DROPS3019
0023-3507-30ACUVAIL0.4 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.419
0023-3507-31ACUVAIL10 in 1 POUCHSOLUTION/ DROPS1019
0023-3507-31ACUVAIL3 in 1 CARTONSOLUTION/ DROPS319

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3507-30EA - Each0023-35074cd5a672-353b-4ff3-ae47-4a09072ad99112012-07-24
0023-3507-31EA - Each0023-3507398645df-bfeb-4754-9905-34d9c737ffb612021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketorolac tromethamineACTIVE INGREDIENT4EVE5946BQACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
ketorolacACTIVE MOIETYYZI5105V0LACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
hydrochloric acidINACTIVE INGREDIENTQTT17582CBACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
sodium chlorideINACTIVE INGREDIENT451W47IQ8XACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
sodium hydroxideINACTIVE INGREDIENT55X04QC32IACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8
waterINACTIVE INGREDIENT059QF0KO0RACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3507ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]19Current NDC, Legacy NDC, 6 package rows20240730_3cea5803-a446-4d2c-9747-f3fb034332c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858366ACUVAIL 0.45 % Ophthalmic SolutionPSN3cea5803-a446-4d2c-9747-f3fb034332c819
858364ketorolac tromethamine 0.45 % Ophthalmic SolutionPSN3cea5803-a446-4d2c-9747-f3fb034332c819
858366ketorolac tromethamine 4.5 MG/ML Ophthalmic Solution [Acuvail]SBD3cea5803-a446-4d2c-9747-f3fb034332c819
858364ketorolac tromethamine 4.5 MG/ML Ophthalmic SolutionSCD3cea5803-a446-4d2c-9747-f3fb034332c819
858366Acuvail 0.45 % Ophthalmic SolutionSY3cea5803-a446-4d2c-9747-f3fb034332c819
858364ketorolac tromethamine 0.45 % Ophthalmic SolutionSY3cea5803-a446-4d2c-9747-f3fb034332c819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-3507-05000233507055 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE2009-08-010000-00-00YesNoCurrent
0023-3507-300002335073030 VIAL, SINGLE-USE in 1 CARTON (0023-3507-30) > .4 mL in 1 VIAL, SINGLE-USE2009-08-012022-04-30NoNoCurrent
0023-3507-31000233507313 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE3 pouch2009-08-010000-00-00NoNoCurrent