Simvastatin

Product NDC

68071-3115

11-digit product format

680713115

Labeler code

68071

Product ID

68071-3115_4aa18675-91ae-29b1-e054-00144ff88e88

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA200895

Marketing category

ANDA

Marketing start

2014-12-09

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

2019-12-31

Current FDA listing

Historical FDA.report record