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NDC 60505-3478-03 Amlodipine and Atorvastatin 5; 10 mg/1; mg/1 Details
Amlodipine and Atorvastatin 5; 10 mg/1; mg/1
Amlodipine and Atorvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE.
MedlinePlus Drug Summary
Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 60505-3478-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Amlodipine
Atorvastatin 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. Atorvastatin 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. Atorvastatin 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). Atorvastatin 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 atorvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
Related Packages: 60505-3478-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Atorvastatin
Product Information
| NDC | 60505-3478 |
|---|---|
| Product ID | 60505-3478_a8614d7b-ff0d-a02c-983a-d0745908a702 |
| Associated GPIs | 40992502150320 |
| GCN Sequence Number | 053689 |
| GCN Sequence Number Description | amlodipine/atorvastatin TABLET 5 MG-10 MG ORAL |
| HIC3 | M4I |
| HIC3 Description | ANTIHYPERLIPID- HMG-COA RI-CALCIUM CHANNEL BLOCKER |
| GCN | 21391 |
| HICL Sequence Number | 025951 |
| HICL Sequence Number Description | AMLODIPINE BESYLATE/ATORVASTATIN CALCIUM |
| Brand/Generic | Generic |
| Proprietary Name | Amlodipine and Atorvastatin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amlodipine and Atorvastatin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205199 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-3478-03 (60505347803)
| NDC Package Code | 60505-3478-3 |
|---|---|
| Billing NDC | 60505347803 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (60505-3478-3) |
| Marketing Start Date | 2020-07-29 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.83567 |
| Pricing Unit | EA |
| Effective Date | 2024-01-17 |
| NDC Description | AMLODIPINE-ATORVAST 5-10 MG |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |