Ezetimibe and Simvastatin

Product NDC

43598-583

11-digit product format

435980583

Labeler code

43598

Product ID

43598-583_e581fc12-9c0e-3797-e284-dcc1aa84a0e7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ezetimibe and Simvastatin

Dosage form

TABLET

Route

ORAL

Labeler

Dr.Reddys Laboratories Inc

Application

ANDA200909

Marketing category

ANDA

Marketing start

2017-04-26

Marketing end

0000-00-00

Substance

EZETIMIBE; SIMVASTATIN

Active strength

10 mg/1; mg/1

Pharmacologic classes

Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record