Ketorolac Tromethamine

Product NDC
50090-5013
11-digit product format
500905013
Labeler code
50090
Product ID
50090-5013_5c1c882c-6204-47f8-a47f-b9bc82cc5d83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA204216
Marketing category
ANDA
Marketing start
2020-01-21
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5013KETOROLAC TROMETHAMINE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]9Legacy NDC20230208_1ed28531-35a0-488f-9699-0d67d1a79ec4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5013-05009050130025 VIAL, SINGLE-DOSE in 1 CARTON (50090-5013-0) > 1 mL in 1 VIAL, SINGLE-DOSE2020-04-160000-00-00NoNoCurrent
50090-5013-1500905013011 mL in 1 VIAL, SINGLE-DOSE (50090-5013-1) 1 ml2020-04-160000-00-00NoNoCurrent