NDC 0245-0036

Prevalite

Cholestyramine

Prevalite is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Cholestyramine.

Product ID0245-0036_1788d34e-a160-474d-a759-65f487dc7634
NDC0245-0036
Product TypeHuman Prescription Drug
Proprietary NamePrevalite
Generic NameCholestyramine
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date1996-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA073263
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameCHOLESTYRAMINE
Active Ingredient Strength4 g/5.5g
Pharm ClassesBile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0245-0036-23

231 g in 1 CAN (0245-0036-23)
Marketing Start Date1996-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-0036-89 [00245003689]

Prevalite POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA073263
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-05

NDC 0245-0036-60 [00245003660]

Prevalite POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA073263
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-02-01

NDC 0245-0036-42 [00245003642]

Prevalite POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA073263
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-02-01

NDC 0245-0036-23 [00245003623]

Prevalite POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA073263
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-02-01

Drug Details

Active Ingredients

IngredientStrength
CHOLESTYRAMINE4 g/5.5g

OpenFDA Data

SPL SET ID:dd434ef8-8af3-434c-a0a0-9a0b18459ba0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848951
  • 1801279

    • Pharmacological Class

    • Bile Acid Sequestrant [EPC]
    • Bile-acid Binding Activity [MoA]

    NDC Crossover Matching brand name "Prevalite" or generic name "Cholestyramine"

    NDCBrand NameGeneric Name
    0245-0036Prevalitecholestyramine
    0185-0940CholestyramineCholestyramine
    0245-0536CholestyramineCholestyramine
    0832-0536CholestyramineCholestyramine
    27241-134CholestyramineCholestyramine
    42806-265CHOLESTYRAMINEcholestyramine
    42806-266CHOLESTYRAMINEcholestyramine
    42806-267CHOLESTYRAMINEcholestyramine
    49884-465Cholestyraminecholestyramine
    49884-466Cholestyraminecholestyramine
    50090-3415Cholestyraminecholestyramine
    50090-3845CHOLESTYRAMINECHOLESTYRAMINE
    51224-011CholestyramineCholestyramine
    62559-620CholestyramineCholestyramine
    63629-2161Cholestyraminecholestyramine
    63629-2162Cholestyraminecholestyramine
    63629-2163Cholestyraminecholestyramine
    63629-2164Cholestyraminecholestyramine
    51224-009Cholestyramine LightCholestyramine
    56156-001Cholestyramine LightCholestyramine
    49884-936QUESTRANCholestyramine
    49884-937QUESTRANCholestyramine

    Trademark Results [Prevalite]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREVALITE
    PREVALITE
    74236957 1853998 Live/Registered
    UPSHER-SMITH LABORATORIES, LLC
    1992-01-13
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