Ketorolac Tromethamine

Product NDC

0517-0601

11-digit product format

005170601

Labeler code

0517

Product ID

0517-0601_75dc1361-b8f8-44ac-980d-47c08d7307cf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

KETOROLAC TROMETHAMINE

Dosage form

INJECTION, SOLUTION

Route

INTRAMUSCULAR; INTRAVENOUS

Labeler

American Regent, Inc.

Application

ANDA078145

Marketing category

ANDA

Marketing start

2008-05-30

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

2019-12-31

Current FDA listing

Historical FDA.report record