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NDC 68788-9429-01 simvastatin 80 mg/1 Details

simvastatin 80 mg/1

simvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is SIMVASTATIN.

MedlinePlus Drug Summary

Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Simvastatin is also used to decrease the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol (''bad cholesterol'') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol (''good cholesterol'') in the blood. Simvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with simvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Related Packages: 68788-9429-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simvastatin

Product Information

NDC	68788-9429
Product ID	68788-9429_2148c5fd-f2d5-4104-a622-8d2dfd560a14
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	simvastatin
Proprietary Name Suffix	n/a
Non-Proprietary Name	simvastatin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	80
Active Ingredient Units	mg/1
Substance Name	SIMVASTATIN
Labeler Name	Preferred Pharmaceuticals, Inc.
Pharmaceutical Class	HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078155
Listing Certified Through	2024-12-31

Package

NDC 68788-9429-01 (68788942901)

Pricing Information	N/A
NDC Package Code	68788-9429-1
Billing NDC	68788942901
Package	100 TABLET, FILM COATED in 1 BOTTLE (68788-9429-1)
Marketing Start Date	2014-10-21
NDC Exclude Flag	N