Colesevelam Hydrochloride

Product NDC
42291-147
11-digit product format
422910147
Labeler code
42291
Product ID
42291-147_d5798ba9-342d-f155-e053-2a95a90a79ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESEVELAM HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA091600
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-147-18EA - Each42291-14703c49a38-a392-4656-9ace-edbf929db27512018-07-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-147-1842291014718180 TABLET, COATED in 1 BOTTLE (42291-147-18) 2018-06-180000-00-00NoNoCurrent