Cholestyramine powders is 1) Cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. This formulation utilizes a powder, for suspension delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-508 and is authorized under FDA application ANDA219318.
Identification & Billing
NDC Package Code
42571-508-29
Package Description
60 POUCH in 1 CARTON / 9 g in 1 POUCH (42571-508-04)
11-Digit Billing Format
42571050829
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
- RxCUI: 848943 - cholestyramine resin 4 GM Powder for Oral Suspension
- RxCUI: 848943 - cholestyramine resin 4000 MG Powder for Oral Suspension
- RxCUI: 848943 - cholestyramine resin 4 GM per 9 GM Powder for Oral Suspension
Clinical Specifications
Proprietary Name
Cholestyramine
Non-Proprietary Name
Cholestyramine
Substance Name
Cholestyramine
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
1) Cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for oral suspension may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight.Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:-LDL-C = Total cholesterol - [(TG/5) + HDL-C]For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated.Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered.Since the goal of treatment is to lower LDL-C, the NCEP
4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below.
Definite
Atherosclerotic
Disease*
Two or More
Other Risk
Factors**
LDL-Cholesterol mg/dL (mmol/L)
Initiation
Level
Goal
NO
NO
≥190 (≥4.9)
<160 (<4.1)
NO
YES
≥160 (≥4.1)
<130 (<3.4)
YES
YES or NO
≥130 (≥3.4)
≤100 (≤2.6)
*Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).**Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L).Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression
2,3and increase the rate of regression
3of coronary atherosclerosis.
2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.
Regulatory & Marketing
Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA219318
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2026
Listing Expiration
12-31-2027
Hierarchy Structure
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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