FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
70518-1159
11-digit product format
705181159
Labeler code
70518
Product ID
70518-1159_6c4534ec-ecbd-cf9a-e053-2991aa0a0c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
REMEDYREPACK INC.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2018-05-07
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
30 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
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1159-02025-11-11C16284748780-19d75b9d0-d49e-f424-e053-dadaa90a57ceKetorolac Tromethamine Injection, USP
70518-1159-02020-01-31C16284748780-19d75b9d0-d49e-f424-e053-dadaa90a57ceKetorolac Tromethamine Injection, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1159KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.]1Legacy NDC20180516_cccbc3cc-4df5-4f99-b89e-2915eaef83e7.zip