RISPERDAL

Product NDC

50458-301

11-digit product format

504580301

Labeler code

50458

Product ID

50458-301_ebac424e-3ee1-4b30-9bc5-739c8eb7f87f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risperidone

Dosage form

TABLET

Route

ORAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA020272

Marketing category

NDA

Marketing start

1993-12-29

Marketing end

0000-00-00

Substance

RISPERIDONE

Active strength

0 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

2023-12-31

Current FDA listing

Historical FDA.report record