FDA.reportPublic FDA data

Colesevelam hydrochloride

Product NDC
63629-8860
11-digit product format
636298860
Labeler code
63629
Product ID
63629-8860_ea570adf-f7b9-4e17-a7db-92e9f70a1dbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam hydrochloride
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210316
Marketing category
ANDA
Marketing start
2019-05-09
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
3.75 g/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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE3.75 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP4SG24WI5Q
Rxcui866905

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
63629-8860-1Colesevelam hydrochloride1 in 1 PACKETPOWDER, FOR SUSPENSION1110
63629-8860-1Colesevelam hydrochloride30 in 1 CARTONPOWDER, FOR SUSPENSION30110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8860-1EA - Each63629-886030f02888-9d61-4b72-a6bc-a37108dff74112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8860COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]110Current NDC, Legacy NDC, 2 package rows20240823_652fbd7b-2702-4db6-8691-be93c61bd9d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSN652fbd7b-2702-4db6-8691-be93c61bd9d6110
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCD652fbd7b-2702-4db6-8691-be93c61bd9d6110
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSY652fbd7b-2702-4db6-8691-be93c61bd9d6110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8860-16362988600130 PACKET in 1 CARTON (63629-8860-1) / 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2022-08-190000-00-00NoNoCurrent