FDA.reportPublic FDA data

Welchol

Product NDC
65597-701
11-digit product format
655970701
Labeler code
65597
Product ID
65597-701_3e806127-4a87-41cc-9b17-a77e20bb2452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA021176
Marketing category
NDA
Marketing start
2000-09-01
Marketing end
2025-09-30
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
625 mg/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-701-18EA - Each65597-70194ce0a17-5983-4799-92f2-1dec7e91416d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.]17
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.]17
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOL ALGINATEINACTIVE INGREDIENT26CD3J2R0CWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
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
65597-701WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION WELCHOL (COLESEVELAM HYDROCHLORIDE) BAR, CHEWABLE [DAIICHI SANKYO INC.]35Legacy NDC20220617_4a06d3b2-7229-4398-baba-5d0a72f63821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866912Welchol 625 MG Oral TabletPSN725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBD725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866910colesevelam hydrochloride 625 MG Oral TabletSCD725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866912Welchol 625 MG Oral TabletSY725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866910colesevelam HCl 625 MG Oral TabletPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907Welchol 3.75 GM Powder for Oral SuspensionPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866912Welchol 625 MG Oral TabletPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]SBDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866910colesevelam hydrochloride 625 MG Oral TabletSCDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907Welchol 3.75 GM Powder for Oral SuspensionSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907Welchol 3750 MG Powder for Oral SuspensionSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866912Welchol 625 MG Oral TabletSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65597-701-1865597070118180 TABLET, FILM COATED in 1 BOTTLE (65597-701-18) 2000-09-010000-00-00NoNoCurrent