KETOROLAC TROMETHAMINE

Product NDC
72189-054
11-digit product format
721890054
Labeler code
72189
Product ID
72189-054_9624d675-0b80-8630-e053-2a95a90a2fd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA076109
Marketing category
ANDA
Marketing start
2019-10-30
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
5 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
72189-054-052023-01-30C16284748780-1f386c649-c1d4-0266-e053-dadaa90a7c1aKETOROLAC TROMETHAMINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-054-05KETOROLAC TROMETHAMINE1 mL in 1 BOTTLESOLUTION/ DROPS11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-054-05ML - Milliliter72189-0545493486a-1bf1-423b-91ae-8bc2cc5d46c912019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-054KETOROLAC TROMETHAMINE SOLUTION/ DROPS [DIRECT RX]1Legacy NDC, 1 package rows20191123_9624d675-0b7f-8630-e053-2a95a90a2fd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN9624d675-0b7f-8630-e053-2a95a90a2fd01
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD9624d675-0b7f-8630-e053-2a95a90a2fd01
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY9624d675-0b7f-8630-e053-2a95a90a2fd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-054-05721890054051 mL in 1 BOTTLE (72189-054-05) 1 ml2019-10-300000-00-00NoNoCurrent