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NDC 43598-0230-18 Colesevelam Hydrochloride 625 mg/1 Details
Colesevelam Hydrochloride 625 mg/1
Colesevelam Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr.Reddys Laboratories Inc. The primary component is COLESEVELAM HYDROCHLORIDE.
MedlinePlus Drug Summary
Colesevelam is used in adults along with diet, weight loss, and exercise to reduce the amount of cholesterol and certain fatty substances in the blood alone or in combination with other cholesterol-lowering medications known as HMG-CoA reductase inhibitors (statins). Colesevelam is also used alone or in combination with HMG-CoA reductase inhibitors in certain boys and in girls, ages 10 to 17, with familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally) to decrease the amount of cholesterol and other fatty substances in the blood. Colesevelam is also used along with diet and exercise to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Colesevelam is in a class of medications called bile acid sequestrants. It works by binding bile acids in your intestines to form a product that is removed from the body. Bile acids are made when cholesterol is broken down in your body. Removing these bile acids helps to lower your blood cholesterol. 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: 43598-0230-18Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Colesevelam
Product Information
NDC | 43598-0230 |
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Product ID | 43598-230_1afa82f5-9ea2-5d75-688e-a44a867bd377 |
Associated GPIs | 39100016100330 |
GCN Sequence Number | 046172 |
GCN Sequence Number Description | colesevelam HCl TABLET 625 MG ORAL |
HIC3 | D7L |
HIC3 Description | BILE SALT SEQUESTRANTS |
GCN | 16300 |
HICL Sequence Number | 021452 |
HICL Sequence Number Description | COLESEVELAM HCL |
Brand/Generic | Generic |
Proprietary Name | Colesevelam Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Colesevelam Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 625 |
Active Ingredient Units | mg/1 |
Substance Name | COLESEVELAM HYDROCHLORIDE |
Labeler Name | Dr.Reddys Laboratories Inc |
Pharmaceutical Class | Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA210889 |
Listing Certified Through | 2024-12-31 |
Package
NDC 43598-0230-18 (43598023018)
NDC Package Code | 43598-230-18 |
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Billing NDC | 43598023018 |
Package | 180 TABLET in 1 BOTTLE (43598-230-18) |
Marketing Start Date | 2018-10-05 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.25227 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | COLESEVELAM 625 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |