Simvastatin

Product NDC

68071-2092

11-digit product format

680712092

Labeler code

68071

Product ID

68071-2092_62edd9c2-4534-af52-e053-2a91aa0aacab

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Simvastatin

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NuCare Pharmaceuticals,Inc.

Application

ANDA077837

Marketing category

ANDA

Marketing start

2006-12-20

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