Risperidone

Product NDC

0378-3502

11-digit product format

003783502

Labeler code

0378

Product ID

0378-3502_bd55c402-c772-4adf-a9cc-129ab7f67fee

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risperidone

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA076288

Marketing category

ANDA

Marketing start

2008-09-17

Marketing end

2020-05-31

Substance

RISPERIDONE

Active strength

0 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record