NDC 21695-779

Welchol

Colesevelam Hydrochloride

Welchol is a Oral For Suspension in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Colesevelam Hydrochloride.

Product ID21695-779_fc274f83-4cd6-47bd-b43e-53a0bf345f11
NDC21695-779
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 NameRebel Distributors Corp
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength4 g/1
Pharm ClassesBile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-779-30

30 FOR SUSPENSION in 1 BOX (21695-779-30)
Marketing Start Date2010-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-779-30 [21695077930]

Welchol FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022362
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE3.75 g/1

OpenFDA Data

SPL SET ID:fc274f83-4cd6-47bd-b43e-53a0bf345f11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866910
  • 866907
  • 866912
  • 866905

    • 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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