Dutasteride

Product NDC

0054-0395

11-digit product format

000540395

Labeler code

0054

Product ID

0054-0395_6f137001-db0e-4fcb-913a-c4c8a9a602e1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dutasteride

Dosage form

CAPSULE

Route

ORAL

Labeler

West-Ward Pharmaceuticals Corp.

Application

ANDA202204

Marketing category

ANDA

Marketing start

2013-08-01

Marketing end

0000-00-00

Substance

DUTASTERIDE

Active strength

1 mg/1

Pharmacologic classes

5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record