Ketorolac Tromethamine

Product NDC
52584-585
11-digit product format
525840585
Labeler code
52584
Product ID
52584-585_1e679a30-9c2d-4fc1-97dd-38bb90206aab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2018-06-04
Marketing end
2021-10-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-585-46525840585461 VIAL, SINGLE-DOSE in 1 BAG (52584-585-46) > 2 mL in 1 VIAL, SINGLE-DOSE2018-06-042021-10-31NoNoCurrent