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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
P4SG24WI5QCOLESEVELAM HYDROCHLORIDE182815-44-7COLESEVELAM HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7811-05009078110090 TABLET, FILM COATED in 1 BOTTLE (50090-7811-0) 2025-12-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Colesevelam HCLA-S Medication Solutions2025-12-30Human Prescription Drug Label1