Dutasteride

Product NDC

68382-641

11-digit product format

683820641

Labeler code

68382

Product ID

68382-641_791e9054-ec90-45b1-bd3e-7dbc689399ac

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dutasteride

Dosage form

CAPSULE, LIQUID FILLED

Route

ORAL

Labeler

Zydus Pharmaceuticals (USA) Inc.

Application

ANDA204373

Marketing category

ANDA

Marketing start

2018-05-16

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

2019-12-31

Current FDA listing

Historical FDA.report record