Ketorolac Tromethamine

Product NDC
70518-2608
11-digit product format
705182608
Labeler code
70518
Product ID
70518-2608_9fd9bf8a-0330-aa21-e053-2995a90adbff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
REMEDYREPACK INC.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2020-03-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2608-02024-09-16C16284748780-1d6a99b39-87c1-a426-e053-dadaa90af4c25e615ee5-db85-4c21-b9d6-ba5eb9ce823a
70518-2608-02022-01-28C16284748780-1d6a99b39-87c1-a426-e053-dadaa90af4c25e615ee5-db85-4c21-b9d6-ba5eb9ce823a

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2608-07051826080025 VIAL, SINGLE-DOSE in 1 CARTON (70518-2608-0) > 2 mL in 1 VIAL, SINGLE-DOSE (70518-2608-1) 2020-03-010000-00-00NoNoCurrent