FDA.reportPublic FDA data

Colesevelam HCL

Product NDC
67877-506
11-digit product format
678770506
Labeler code
67877
Product ID
67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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

Additional Listing Data#

Finished product
Yes
Brand name base
Colesevelam HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP4SG24WI5Q
Rxcui866910

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-506-05Colesevelam HCL500 in 1 BOTTLETABLET, FILM COATED50014
67877-506-30Colesevelam HCL30 in 1 BOTTLETABLET, FILM COATED3014
67877-506-51Colesevelam HCL180 in 1 BOTTLETABLET, FILM COATED18014
67877-506-90Colesevelam HCL90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-506-51EA - Each67877-506d4f9b01a-58f9-4ad2-8a1b-7e28c56811f212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-506COLESEVELAM HCL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]14Current NDC, Legacy NDC, 4 package rows20240209_4ffd02a3-86b8-4af7-b539-aa32e38c6b12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7105
866910colesevelam hydrochloride 625 MG Oral TabletSCD5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7105
866910colesevelam HCl 625 MG Oral TabletPSNffac398c-3eb7-482a-80ce-0ad2cbd2bdca103
866910colesevelam hydrochloride 625 MG Oral TabletSCDffac398c-3eb7-482a-80ce-0ad2cbd2bdca103
866910colesevelam HCl 625 MG Oral TabletPSN22cf31e6-59fa-40db-a181-2a12afc3af43100
866910colesevelam hydrochloride 625 MG Oral TabletSCD22cf31e6-59fa-40db-a181-2a12afc3af43100
866910colesevelam HCl 625 MG Oral TabletPSN66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb16
866910colesevelam hydrochloride 625 MG Oral TabletSCD66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb16
866910colesevelam HCl 625 MG Oral TabletPSN4ffd02a3-86b8-4af7-b539-aa32e38c6b1214
866910colesevelam hydrochloride 625 MG Oral TabletSCD4ffd02a3-86b8-4af7-b539-aa32e38c6b1214
866910colesevelam HCl 625 MG Oral TabletPSN5eb26657-09cf-4229-a567-1395b58bba6b10
866910colesevelam hydrochloride 625 MG Oral TabletSCD5eb26657-09cf-4229-a567-1395b58bba6b10
866910colesevelam HCl 625 MG Oral TabletPSN62ea3a03-5cd0-4adc-8464-c7d8b00cd0de1
866910colesevelam hydrochloride 625 MG Oral TabletSCD62ea3a03-5cd0-4adc-8464-c7d8b00cd0de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-506-0567877050605500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05) 2018-10-060000-00-00NoNoCurrent
67877-506-306787705063030 TABLET, FILM COATED in 1 BOTTLE (67877-506-30) 2018-10-060000-00-00NoNoCurrent
67877-506-5167877050651180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51) 2018-10-060000-00-00NoNoCurrent
67877-506-906787705069090 TABLET, FILM COATED in 1 BOTTLE (67877-506-90) 2018-10-060000-00-00NoNoCurrent