Ketorolac Tromethamine

Product NDC

69543-386

11-digit product format

695430386

Labeler code

69543

Product ID

69543-386_97c63b31-3f13-4bfa-8e19-ae23666d77b1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

KETOROLAC TROMETHAMINE

Dosage form

INJECTION, SOLUTION

Route

INTRAMUSCULAR; INTRAVENOUS

Labeler

Virtus Pharmaceuticals, LLC

Application

ANDA209900

Marketing category

ANDA

Marketing start

2017-09-15

Marketing end

2020-05-31

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