FDA.reportPublic FDA data

Welchol

Product NDC
21695-781
11-digit product format
216950781
Labeler code
21695
Product ID
21695-781_fc274f83-4cd6-47bd-b43e-53a0bf345f11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021176
Marketing category
NDA
Marketing start
2000-09-01
Marketing end
0000-00-00
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
625 mg/1
Pharmacologic classes
Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-781-782019-09-24C16284748780-1934fe258-4b36-48b1-e053-8cdaa90a720aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-781-78Welchol180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-781-78EA - Each21695-7810dc3c492-6cfc-4edd-bb9f-5ecc5e43651812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOL ALGINATEINACTIVE INGREDIENT26CD3J2R0CWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-781WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110127_fc274f83-4cd6-47bd-b43e-53a0bf345f11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866910colesevelam HCl 625 MG Oral TabletPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907Welchol 3.75 GM Powder for Oral SuspensionPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866912Welchol 625 MG Oral TabletPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]SBDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866910colesevelam hydrochloride 625 MG Oral TabletSCDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSYfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907Welchol 3.75 GM Powder for Oral SuspensionSYfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907Welchol 3750 MG Powder for Oral SuspensionSYfc274f83-4cd6-47bd-b43e-53a0bf345f111
866912Welchol 625 MG Oral TabletSYfc274f83-4cd6-47bd-b43e-53a0bf345f111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-781-7821695078178180 in 1 BOTTLEHistorical