FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
68071-2400
11-digit product format
680712400
Labeler code
68071
Product ID
68071-2400_4cecb11c-71ec-df25-e063-6394a90a2dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078434
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2400-52023-01-30C16284748780-1f386c649-d21d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2400-5Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION52
68071-2400-5Ketorolac Tromethamine1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2400KETOROLAC TROMETHAMINE SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 2 package rows20210514_c2290fd1-2985-1275-e053-2995a90ad5fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNc2290fd1-2985-1275-e053-2995a90ad5fa2
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDc2290fd1-2985-1275-e053-2995a90ad5fa2
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYc2290fd1-2985-1275-e053-2995a90ad5fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2400-5680712400051 BOTTLE, DROPPER in 1 CARTON (68071-2400-5) / 5 mL in 1 BOTTLE, DROPPER2021-05-120000-00-00NoNoCurrent