Colesevelam hydrochloride

Product NDC
50090-7604
11-digit product format
500907604
Labeler code
50090
Product ID
50090-7604_1f95ff46-b4bf-42d3-b39b-b7221c7e07da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209946
Marketing category
ANDA
Marketing start
2020-10-19
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7604-05009076040090 TABLET in 1 BOTTLE (50090-7604-0) 90 tablet2025-07-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Colesevelam hydrochlorideA-S Medication Solutions2025-07-16HUMAN PRESCRIPTION DRUG LABEL1