Simvastatin

Product NDC

50268-712

11-digit product format

502680712

Labeler code

50268

Product ID

50268-712_8e8213d2-aa27-cae0-e053-2a95a90a71ce

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

AvPAK

Application

ANDA077691

Marketing category

ANDA

Marketing start

2014-12-02

Marketing end

0000-00-00

Substance

SIMVASTATIN

Active strength

5 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