COLESEVELAM HYDROCHLORIDE

Product NDC
63629-2446
11-digit product format
636292446
Labeler code
63629
Product ID
63629-2446_e4687c20-cc7a-422f-aeb4-3b20701f9c1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208670
Marketing category
ANDA
Marketing start
2019-12-02
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
63629-2446-1EA - Each63629-24468ff1d5ba-ace8-4afa-a94b-85775b25762712021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2446-163629244601180 TABLET, FILM COATED in 1 BOTTLE (63629-2446-1) 2021-02-160000-00-00NoNoCurrent