Ketorolac Tromethamine

Product NDC
70518-3308
11-digit product format
705183308
Labeler code
70518
Product ID
70518-3308_d42563ae-0371-47b7-e053-2995a90a3203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210616
Marketing category
ANDA
Marketing start
2021-12-23
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3308-02023-03-24C16284748780-1f386c649-a6e7-0266-e053-dadaa90a7c1a6cd34ff5-0006-4ccd-9d28-3a359001046e
70518-3308-02023-01-30C16284748780-1f386c649-a6e7-0266-e053-dadaa90a7c1a6cd34ff5-0006-4ccd-9d28-3a359001046e

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3308-07051833080050 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3308-0) 2021-12-230000-00-00NoNoCurrent