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NDC 71610-0232-18 Rosuvastatin Calcium 40 mg/1 Details
Rosuvastatin Calcium 40 mg/1
Rosuvastatin Calcium is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is ROSUVASTATIN CALCIUM.
MedlinePlus Drug Summary
Rosuvastatin 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. Rosuvastatin is also used to decrease the amount of cholesterol 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. Rosuvastatin may also be used together with diet to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 8 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin is used together with diet, and alone or in combination with other medications, to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 7 to 17 years of age who have familial homozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin 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 rosuvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
Related Packages: 71610-0232-18Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Rosuvastatin
Product Information
NDC | 71610-0232 |
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Product ID | 71610-232_e177d76d-1ef4-4218-9e40-07cdf617857b |
Associated GPIs | 39400060100340 |
GCN Sequence Number | 051786 |
GCN Sequence Number Description | rosuvastatin calcium TABLET 40 MG ORAL |
HIC3 | M4D |
HIC3 Description | ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) |
GCN | 19155 |
HICL Sequence Number | 025009 |
HICL Sequence Number Description | ROSUVASTATIN CALCIUM |
Brand/Generic | Generic |
Proprietary Name | Rosuvastatin Calcium |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Rosuvastatin Calcium |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 40 |
Active Ingredient Units | mg/1 |
Substance Name | ROSUVASTATIN CALCIUM |
Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
Pharmaceutical Class | HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA207408 |
Listing Certified Through | 2024-12-31 |
Package
NDC 71610-0232-18 (71610023218)
NDC Package Code | 71610-232-18 |
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Billing NDC | 71610023218 |
Package | 3000 TABLET, FILM COATED in 1 BOTTLE (71610-232-18) |
Marketing Start Date | 2023-03-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |