ROWEEPRA

Product NDC

69102-101

11-digit product format

691020101

Labeler code

69102

Product ID

69102-101_4bdc3df6-2e89-47e0-9d91-f3865f8190e3

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

levetiracetam

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

OWP Pharmaceuticals, Inc.

Application

ANDA090906

Marketing category

ANDA

Marketing start

2016-04-27

Marketing end

0000-00-00

Substance

LEVETIRACETAM

Active strength

500 mg/1

Pharmacologic classes

Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record