Ketorolac Tromethamine

Product NDC
67296-0511
11-digit product format
672960511
Labeler code
67296
Product ID
67296-0511_40d145e6-13f8-41ac-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
67296-0511-1Ketorolac Tromethamine20 in 1 BOTTLETABLET204
67296-0511-2Ketorolac Tromethamine10 in 1 BOTTLETABLET104
67296-0511-3Ketorolac Tromethamine16 in 1 BOTTLETABLET164
67296-0511-4Ketorolac Tromethamine15 in 1 BOTTLETABLET154
67296-0511-5Ketorolac Tromethamine2 in 1 BOTTLETABLET24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0511KETOROLAC TROMETHAMINE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 5 package rows20161109_40d145e6-13f7-41ac-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN40d145e6-13f7-41ac-e054-00144ff8d46c4
834022ketorolac tromethamine 10 MG Oral TabletSCD40d145e6-13f7-41ac-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0511-16729605110120 in 1 BOTTLEHistorical
67296-0511-26729605110210 in 1 BOTTLEHistorical
67296-0511-36729605110316 in 1 BOTTLEHistorical
67296-0511-46729605110415 in 1 BOTTLEHistorical
67296-0511-5672960511052 in 1 BOTTLEHistorical