Indomethacin

Product NDC

10544-216

11-digit product format

105440216

Labeler code

10544

Product ID

10544-216_119174f1-af30-355d-e054-00144ff8d46c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

indomethacin

Dosage form

CAPSULE

Route

ORAL

Labeler

Blenheim Pharmacal, Inc.

Application

ANDA070624

Marketing category

ANDA

Marketing start

2010-11-08

Marketing end

0000-00-00

Substance

INDOMETHACIN

Active strength

50 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record