KETOROLAC TROMETHAMINE

Product NDC
52584-084
11-digit product format
525840084
Labeler code
52584
Product ID
52584-084_bbe25685-e4c3-43ab-9165-aa7d447f1f42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA075772
Marketing category
ANDA
Marketing start
2018-11-13
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
15 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-084-01525840084011 VIAL in 1 BAG (52584-084-01) > 1 mL in 1 VIAL1 vial2018-11-130000-00-00NoNoCurrent