Welchol

Product NDC
68151-4362
11-digit product format
681514362
Labeler code
68151
Product ID
68151-4362_a89a5f2d-405a-4015-a320-e6defa0d0fd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
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
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4362-1Welchol1 in 1 PACKAGETABLET, FILM COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4362WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_725dd631-75be-4e9b-82d8-d2c8dfcb917b.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4362-1681514362011 in 1 PACKAGEHistorical