Ketorolac Tromethamine

Product NDC
50090-2762
11-digit product format
500902762
Labeler code
50090
Product ID
50090-2762_f34dee0a-6efc-449d-b148-7943318df04d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA076109
Marketing category
ANDA
Marketing start
2009-12-07
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
2022-12-31
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2762-0Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS510
50090-2762-0Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2762-0ML - Milliliter50090-2762c2b927d8-5141-441d-a837-96ec1c6e75f312019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2762KETOROLAC TROMETHAMINE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20210417_76f4b8d2-3fe7-4555-92e8-7d63a68633b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN76f4b8d2-3fe7-4555-92e8-7d63a68633b610
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD76f4b8d2-3fe7-4555-92e8-7d63a68633b610
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY76f4b8d2-3fe7-4555-92e8-7d63a68633b610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2762-0500902762001 BOTTLE, DROPPER in 1 CARTON (50090-2762-0) > 5 mL in 1 BOTTLE, DROPPER2017-01-090000-00-00NoNoCurrent