Ketorolac Tromethamine

Product NDC
50090-4635
11-digit product format
500904635
Labeler code
50090
Product ID
50090-4635_eea6412c-a216-4888-9e8d-7d19128b991f
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
2017-01-15
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
2020-12-31
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
50090-4635KETOROLAC TROMETHAMINE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]7Legacy NDC20240124_4bdf1611-af60-4f0b-9bc7-57bc117b0dc6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4635-05009046350025 VIAL in 1 CARTON (50090-4635-0) > 2 mL in 1 VIAL25 vial2019-10-220000-00-00NoNoCurrent
50090-4635-1500904635012 mL in 1 VIAL (50090-4635-1) 2 ml2019-10-220000-00-00NoNoCurrent