Colesevelam HCL

Product NDC
72162-1846
11-digit product format
721621846
Labeler code
72162
Product ID
72162-1846_20fff2f0-3ece-4464-977c-c897847df88e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209038
Marketing category
ANDA
Marketing start
2018-10-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colesevelam HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP4SG24WI5Q
Rxcui866910

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1846-2Colesevelam HCL180 in 1 BOTTLETABLET, FILM COATED180103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1846-2EA - Each72162-184614986253-70e9-4abd-a943-3ed289ceb7f412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1846COLESEVELAM HCL TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 1 package rows20240823_ffac398c-3eb7-482a-80ce-0ad2cbd2bdca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSNffac398c-3eb7-482a-80ce-0ad2cbd2bdca103
866910colesevelam hydrochloride 625 MG Oral TabletSCDffac398c-3eb7-482a-80ce-0ad2cbd2bdca103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1846-272162184602180 TABLET, FILM COATED in 1 BOTTLE (72162-1846-2) 2023-04-20NoNoHistorical