Ketorolac Tromethamine

Product NDC
67296-1412
11-digit product format
672961412
Labeler code
67296
Product ID
67296-1412_c0aa263f-5fb9-59da-e053-2a95a90a5af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA074761
Marketing category
ANDA
Marketing start
2013-05-16
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
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
67296-1412-1Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED103
67296-1412-2Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED203
67296-1412-9Ketorolac Tromethamine2 in 1 BOTTLETABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1412KETOROLAC TROMETHAMINE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 3 package rows20240808_bc2f7fc4-698e-1286-e053-2a95a90a188e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNbc2f7fc4-698e-1286-e053-2a95a90a188e3
834022ketorolac tromethamine 10 MG Oral TabletSCDbc2f7fc4-698e-1286-e053-2a95a90a188e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1412-16729614120110 TABLET, FILM COATED in 1 BOTTLE (67296-1412-1) 2013-05-160000-00-00NoNoCurrent
67296-1412-26729614120220 TABLET, FILM COATED in 1 BOTTLE (67296-1412-2) 2021-04-010000-00-00NoNoCurrent
67296-1412-9672961412092 in 1 BOTTLEHistorical