KETOROLAC TROMETHAMINE

Product NDC
52584-719
11-digit product format
525840719
Labeler code
52584
Product ID
52584-719_8dd3ed85-3d71-4db6-864e-762b426776fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2021-07-14
Marketing end
2023-10-31
Substance
KETOROLAC TROMETHAMINE
Active strength
15 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
52584-719-01525840719011 VIAL, SINGLE-DOSE in 1 BAG (52584-719-01) > 1 mL in 1 VIAL, SINGLE-DOSE2021-07-142023-10-31NoNoCurrent