INDOCIN

Product NDC

42211-102

11-digit product format

422110102

Labeler code

42211

Product ID

42211-102_7b3b36fc-a47e-43cd-88e8-074d97b6e22f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Indomethacin

Dosage form

SUPPOSITORY

Route

RECTAL

Labeler

Iroko Pharmaceuticals, LLC

Application

ANDA073314

Marketing category

ANDA

Marketing start

1992-08-31

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

2019-12-31

Current FDA listing

Historical FDA.report record