COLESEVELAM HYDROCHLORIDE

Product NDC
50090-6994
11-digit product format
500906994
Labeler code
50090
Product ID
50090-6994_d74dadc8-3861-4ff7-92d2-69e983a732e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESEVELAM HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021176
Marketing category
NDA
Marketing start
2022-08-01
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
50090-6994-05009069940090 TABLET, FILM COATED in 1 BOTTLE (50090-6994-0) 2023-12-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
COLESEVELAM HYDROCHLORIDEA-S Medication Solutions2023-12-28HUMAN PRESCRIPTION DRUG LABEL1