Simvastatin

Product NDC

42708-051

11-digit product format

427080051

Labeler code

42708

Product ID

42708-051_d161886d-2a91-449d-98d5-ba50dab2ea61

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

QPharma Inc

Application

ANDA076052

Marketing category

ANDA

Marketing start

2006-06-27

Marketing end

0000-00-00

Substance

SIMVASTATIN

Active strength

20 mg/1

Pharmacologic classes

HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record