Indomethacin

Product NDC

49999-371

11-digit product format

499990371

Labeler code

49999

Product ID

49999-371_57b6c5e6-8b4d-461f-af20-f12a9bb48c4a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Indomethacin

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Application

ANDA091549

Marketing category

ANDA

Marketing start

2011-11-21

Marketing end

0000-00-00

Substance

INDOMETHACIN

Active strength

75 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