Tivorbex

Product NDC

69344-201

11-digit product format

693440201

Labeler code

69344

Product ID

69344-201_6d48a6bc-af86-4501-8855-a5bcbe6061cd

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

indomethacin

Dosage form

CAPSULE

Route

ORAL

Labeler

Egalet US Inc.

Application

NDA204768

Marketing category

NDA

Marketing start

2019-02-04

Marketing end

0000-00-00

Substance

INDOMETHACIN

Active strength

20 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record