indomethacin

Product NDC

42708-030

11-digit product format

427080030

Labeler code

42708

Product ID

42708-030_8a1b394c-6345-4dd8-9d85-aebf109c63a7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

indomethacin

Dosage form

CAPSULE

Route

ORAL

Labeler

QPharma Inc

Application

ANDA090403

Marketing category

ANDA

Marketing start

2016-07-21

Marketing end

0000-00-00

Substance

INDOMETHACIN

Active strength

50 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