Colesevelam HCL

Product NDC
50090-7811
11-digit product format
500907811
Labeler code
50090
Product ID
50090-7811_fc668bf2-580a-4bd9-9649-9538c20745a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-7811-0Colesevelam HCL90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7811-0EA - Each50090-781194a1a1e5-7aa7-4a28-99dd-6bceb3c2dab012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN62ea3a03-5cd0-4adc-8464-c7d8b00cd0de1
866910colesevelam hydrochloride 625 MG Oral TabletSCD62ea3a03-5cd0-4adc-8464-c7d8b00cd0de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7811-05009078110090 TABLET, FILM COATED in 1 BOTTLE (50090-7811-0) 2025-12-05NoNoCurrent