Risperidone

Product NDC

51079-465

11-digit product format

510790465

Labeler code

51079

Product ID

51079-465_a3690b28-f570-7141-e053-2995a90a1b65

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risperidone

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA076288

Marketing category

ANDA

Marketing start

2008-10-06

Marketing end

2020-09-30

Substance

RISPERIDONE

Active strength

4 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record