Indomethacin extended-release

Product NDC

68071-3174

11-digit product format

680713174

Labeler code

68071

Product ID

68071-3174_4af33646-6054-6245-e054-00144ff88e88

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Indomethacin extended-release

Dosage form

CAPSULE

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA202706

Marketing category

ANDA

Marketing start

2015-10-05

Marketing end

0000-00-00

Substance

INDOMETHACIN

Active strength

75 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