simvastatin

Product NDC

42254-129

11-digit product format

422540129

Labeler code

42254

Product ID

42254-129_330e35ed-fd6b-4123-864a-a5aa339c24d6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Rebel Distributors Corp

Application

ANDA078155

Marketing category

ANDA

Marketing start

2008-02-26

Marketing end

0000-00-00

Substance

SIMVASTATIN

Active strength

10 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record