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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

fc274f83-4cd6-47bd-b43e-53a0bf345f11

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 26, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-779
Application NumberNDA022362
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2009
FDA Product Classification

INGREDIENTS (7)

CITRIC ACID MONOHYDRATEInactive
Quantity: 0.048 g in 1 1
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM TRISILICATEInactive
Quantity: 0.024 g in 1 1
Code: C2E1CI501T
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
DIMETHICONEInactive
Quantity: 0.189 g in 1 1
Code: 92RU3N3Y1O
Classification: IACT
ASPARTAMEInactive
Quantity: 0.048 g in 1 1
Code: Z0H242BBR1
Classification: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Quantity: 0.048 g in 1 1
Code: U72Q2I8C85
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Quantity: 0.189 g in 1 1
Code: 26CD3J2R0C
Classification: IACT

colesevelam hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-781
Application NumberNDA021176
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2009
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Quantity: 4.2 mg in 1 1
Code: 70097M6I30
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
HYPROMELLOSESInactive
Quantity: 6.26 mg in 1 1
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 8.6 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Quantity: 141.7 mg in 1 1
Code: OP1R32D61U
Classification: IACT

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 10/6/2009

RECENT MAJOR CHANGES

Indications and Usage (1.1, 1.3) 10/2009
Dosage and Administration (2) 10/2009
Warnings and Precautions (5.6) 10/2009
Adverse Reactions (6.1) 10/2009
Use in Specific Populations (8.4) 10/2009
Clinical Studies (14.1) 10/2009

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/19/2009

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Welchol - FDA Drug Approval Details