NDC 65597-209

Welchol

Colesevelam Hydrochloride

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

Product ID65597-209_5eb2def7-cb23-4442-99bf-ac35d529ec13
NDC65597-209
Product TypeHuman Prescription Drug
Proprietary NameWelchol
Generic NameColesevelam Hydrochloride
Dosage FormBar, Chewable
Route of AdministrationORAL
Marketing Start Date2019-04-04
Marketing CategoryNDA / NDA
Application NumberNDA210895
Labeler NameDaiichi Sankyo Inc.
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength4 g/1
Pharm ClassesBile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65597-209-30

30 PACKAGE in 1 CARTON (65597-209-30) > 1 BAR, CHEWABLE in 1 PACKAGE
Marketing Start Date2019-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65597-209-30 [65597020930]

Welchol BAR, CHEWABLE
Marketing CategoryNDA
Application NumberNDA210895
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-04

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE3.75 g/1

OpenFDA Data

SPL SET ID:4a06d3b2-7229-4398-baba-5d0a72f63821
Manufacturer
UNII

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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