Welchol
These highlights do not include all the information needed to use Welchol safely and effectively. See full prescribing information for Welchol. Welchol (colesevelam hydrochloride) Tablet, Film Coated, for Oral Welchol (colesevelam hydrochloride) For Suspension, for Oral Initial U.S. Approval: 2000
Approved
Approval ID
b9df447c-b65b-45b9-873a-07a2ab6e2d1f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4474
Application NumberNDA021176
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2012
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6136
Application NumberNDA022362
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2012
FDA Product Classification
INGREDIENTS (5)
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT