Ketorolac Tromethamine

Product NDC
52584-725
11-digit product format
525840725
Labeler code
52584
Product ID
52584-725_1d006e3c-6631-44b5-bf66-2c5b0e87cbff
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
2020-05-12
Marketing end
2023-01-31
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [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
52584-725-01525840725011 VIAL, SINGLE-DOSE in 1 BAG (52584-725-01) > 2 mL in 1 VIAL, SINGLE-DOSE2020-05-120000-00-00NoNoCurrent