Primidone

Product NDC

0615-5591

11-digit product format

006155591

Labeler code

0615

Product ID

0615-5591_4bd1672f-54df-4a23-a7cd-dd63d302abdc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Primidone

Dosage form

TABLET

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA084903

Marketing category

ANDA

Marketing start

2001-05-24

Marketing end

0000-00-00

Substance

PRIMIDONE

Active strength

50 mg/1

Pharmacologic classes

Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record