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NDC 82009-0015-10 Simvastatin 40 mg/1 Details
Simvastatin 40 mg/1
Simvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Quallent Pharmaceuticals Health LLC. 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: 82009-0015-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simvastatin
Product Information
NDC | 82009-0015 |
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Product ID | 82009-015_00579b50-3f9a-9f59-e063-6394a90af798 |
Associated GPIs | 39400075000340 |
GCN Sequence Number | 016579 |
GCN Sequence Number Description | simvastatin TABLET 40 MG ORAL |
HIC3 | M4D |
HIC3 Description | ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) |
GCN | 26534 |
HICL Sequence Number | 006312 |
HICL Sequence Number Description | SIMVASTATIN |
Brand/Generic | Generic |
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 | 40 |
Active Ingredient Units | mg/1 |
Substance Name | SIMVASTATIN |
Labeler Name | Quallent Pharmaceuticals Health LLC |
Pharmaceutical Class | HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA200895 |
Listing Certified Through | 2024-12-31 |
Package
NDC 82009-0015-10 (82009001510)
NDC Package Code | 82009-015-10 |
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Billing NDC | 82009001510 |
Package | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-015-10) |
Marketing Start Date | 2022-05-26 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.06758 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | SIMVASTATIN 40 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |