NDC 65597-701

Welchol

Colesevelam Hydrochloride

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

Product ID65597-701_266a7143-c10d-40ee-b217-e565db2295b7
NDC65597-701
Product TypeHuman Prescription Drug
Proprietary NameWelchol
Generic NameColesevelam Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-09-01
Marketing CategoryNDA / NDA
Application NumberNDA021176
Labeler NameDaiichi Sankyo Inc.
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength625 mg/1
Pharm ClassesBile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65597-701-18

180 TABLET, FILM COATED in 1 BOTTLE (65597-701-18)
Marketing Start Date2000-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65597-701-18 [65597070118]

Welchol TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021176
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-09-01

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/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]

    Medicade Reported Pricing

    65597070118 WELCHOL 625 MG TABLET

    Pricing Unit: EA | Drug Type:

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.