Ropinirole Hydrochloride

Product NDC

64679-771

11-digit product format

646790771

Labeler code

64679

Product ID

64679-771_16dc7f02-9997-458e-b829-105cacbcbeab

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ropinirole Hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Wockhardt USA LLC.

Application

ANDA091395

Marketing category

ANDA

Marketing start

2012-08-15

Marketing end

0000-00-00

Substance

ROPINIROLE HYDROCHLORIDE

Active strength

2 mg/1

Pharmacologic classes

Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record