Primidone

Product NDC

42291-508

11-digit product format

422910508

Labeler code

42291

Product ID

42291-508_6a886cd5-878f-0abc-e053-2991aa0aa584

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

primidone

Dosage form

TABLET

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA040586

Marketing category

ANDA

Marketing start

2018-03-28

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record