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NDC 00527-2580-37 Fluvastatin Sodium 80 mg/1 Details
Fluvastatin Sodium 80 mg/1
Fluvastatin Sodium is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lannett Company, Inc.. The primary component is FLUVASTATIN SODIUM.
MedlinePlus Drug Summary
Fluvastatin 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. Fluvastatin 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. Fluvastatin 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). Fluvastatin 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 fluvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
Related Packages: 00527-2580-37Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluvastatin
Product Information
NDC | 00527-2580 |
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Product ID | 0527-2580_0ead960b-0e48-cf8a-e063-6294a90aa925 |
Associated GPIs | 39400030107530 |
GCN Sequence Number | 046757 |
GCN Sequence Number Description | fluvastatin sodium TAB ER 24H 80 MG ORAL |
HIC3 | M4D |
HIC3 Description | ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) |
GCN | 89424 |
HICL Sequence Number | 008946 |
HICL Sequence Number Description | FLUVASTATIN SODIUM |
Brand/Generic | Generic |
Proprietary Name | Fluvastatin Sodium |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Fluvastatin Sodium |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 80 |
Active Ingredient Units | mg/1 |
Substance Name | FLUVASTATIN SODIUM |
Labeler Name | Lannett Company, Inc. |
Pharmaceutical Class | HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA209397 |
Listing Certified Through | 2025-12-31 |
Package
NDC 00527-2580-37 (00527258037)
NDC Package Code | 0527-2580-37 |
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Billing NDC | 00527258037 |
Package | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37) |
Marketing Start Date | 2022-03-14 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 3.24133 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | FLUVASTATIN ER 80 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |