NDC 65597-903

Welchol

Colesevelam Hydrochloride

Welchol is a Oral For Suspension in the Human Prescription Drug category. It is labeled and distributed by Daiichi Sankyo Inc.. The primary component is Colesevelam Hydrochloride.

Product ID65597-903_5eb2def7-cb23-4442-99bf-ac35d529ec13
NDC65597-903
Product TypeHuman Prescription Drug
Proprietary NameWelchol
Generic NameColesevelam Hydrochloride
Dosage FormFor Suspension
Route of AdministrationORAL
Marketing Start Date2010-01-01
Marketing CategoryNDA / NDA
Application NumberNDA022362
Labeler NameDaiichi Sankyo Inc.
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength2 g/1
Pharm ClassesBile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC SPL Data Element Entries

NDC 65597-903-60 [65597090360]

Welchol FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022362
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-01
Marketing End Date2019-01-16

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE1.875 g/1

OpenFDA Data

SPL SET ID:4a06d3b2-7229-4398-baba-5d0a72f63821
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866903
  • 866900
  • 866910
  • 866905
  • 866912
  • 866907
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Welchol" or generic name "Colesevelam Hydrochloride"

    NDCBrand NameGeneric Name
    0713-0879Welcholcolesevelam hydrochloride
    0713-0880Welcholcolesevelam hydrochloride
    21695-779Welcholcolesevelam hydrochloride
    21695-781Welcholcolesevelam hydrochloride
    68151-4362WelcholWelchol
    65597-701WelcholWelchol
    65597-903WelcholWelchol
    65597-902WelcholWelchol
    65597-209WelcholWelchol
    65597-210WelcholWelchol
    65597-208WelcholWelchol
    0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDE
    0713-0935COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE
    0713-0936COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE
    27808-190Colesevelam hydrochlorideColesevelam hydrochloride
    42291-147Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDE
    43598-230Colesevelam HydrochlorideColesevelam Hydrochloride
    51407-159Colesevelam HydrochlorideColesevelam Hydrochloride
    51407-336Colesevelam hydrochlorideColesevelam hydrochloride
    51660-995Colesevelam hydrochloridecolesevelam hydrochloride
    51660-996Colesevelam hydrochloridecolesevelam hydrochloride
    60687-385Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDE

    Trademark Results [Welchol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    WELCHOL
    WELCHOL
    78817367 3473865 Live/Registered
    DAIICHI SANKYO, INC.
    2006-02-17
    WELCHOL
    WELCHOL
    78276948 3122563 Live/Registered
    Daiichi Sankyo, Inc.
    2003-07-21
    WELCHOL
    WELCHOL
    75901091 2493507 Live/Registered
    DAIICHI SANKYO, INC.
    2000-01-20
    WELCHOL
    WELCHOL
    75899011 not registered Dead/Abandoned
    SANKYO COMPANY LIMITED
    2000-01-19
    WELCHOL
    WELCHOL
    75067655 not registered Dead/Abandoned
    SANKYO COMPANY LIMITED
    1996-03-05

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