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NDC 00904-7103-10 Ezetimibe 10 mg/1 Details
Ezetimibe 10 mg/1
Ezetimibe is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is EZETIMIBE.
MedlinePlus Drug Summary
Ezetimibe is used along with diet, alone or in combination with another cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins]) to reduce the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood in adults and children 10 years of age or older who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). It is also used along with diet, alone or in combination with other cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins] or fenofibrate) in adults who have too many fats in the blood. Ezetimibe is also used with other medications to reduce the amount of LDL cholesterol in the blood in adults and children 10 years of age or older who have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). It is also used to reduce the amount of other fatty substances in the blood in adults and children 9 years of age or older who have homozygous familial sitosterolemia (an inherited condition in which fatty substances from vegetable oils, nuts, and other plant-based foods cannot be removed from the body normally). Ezetimibe is in a class of medications called cholesterol-lowering medications. It works by preventing the absorption of cholesterol in the intestine. 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 may help prevent heart disease, angina (chest pain), strokes, and heart attacks.
Related Packages: 00904-7103-10Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Ezetimibe
Product Information
NDC | 00904-7103 |
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Product ID | 0904-7103_067a6c29-522c-4fb3-ab5f-277351f9f3d8 |
Associated GPIs | 39300030000320 |
GCN Sequence Number | 051214 |
GCN Sequence Number Description | ezetimibe TABLET 10 MG ORAL |
HIC3 | M4E |
HIC3 Description | LIPOTROPICS |
GCN | 18387 |
HICL Sequence Number | 024459 |
HICL Sequence Number Description | EZETIMIBE |
Brand/Generic | Generic |
Proprietary Name | Ezetimibe |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Ezetimibe |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/1 |
Substance Name | EZETIMIBE |
Labeler Name | Major Pharmaceuticals |
Pharmaceutical Class | Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA209234 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00904-7103-10 (00904710310)
NDC Package Code | 0904-7103-10 |
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Billing NDC | 00904710310 |
Package | 20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2023-08-25 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.08444 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | EZETIMIBE 10 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |