Niacin

Product NDC

68382-201

11-digit product format

683820201

Labeler code

68382

Product ID

68382-201_e6e83586-3303-6e11-3c94-886df977c579

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Niacin

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Zydus Pharmaceuticals USA Inc

Application

NDA020381

Marketing category

NDA

Marketing start

2014-06-30

Marketing end

2019-07-09

Substance

NIACIN

Active strength

500 mg/1

Pharmacologic classes

Nicotinic Acid [EPC],Nicotinic Acids [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record