FDA.reportPublic FDA data

Colesevelam Hydrochloride

Product NDC
60687-385
11-digit product format
606870385
Labeler code
60687
Product ID
60687-385_45381a76-f843-d419-e063-6294a90a83de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091600
Marketing category
ANDA
Marketing start
2018-08-09
Marketing end
2026-11-30
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
625 mg/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colesevelam Hydrochloride

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
60687-385-25Colesevelam Hydrochloride30 in 1 BOX, UNIT-DOSETABLET, FILM COATED308
60687-385-95Colesevelam Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-385-25EA - Each60687-3856555cd5a-0df8-4d1d-83b0-69aa2622cdf712018-08-13
60687-385-95EA - Each60687-38532100dbb-05f2-4985-82df-c7c82604aaa312018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-385COLESEVELAM HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241123_87bf6310-cfc4-4cb4-966e-8561b3880e36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN87bf6310-cfc4-4cb4-966e-8561b3880e368
866910colesevelam hydrochloride 625 MG Oral TabletSCD87bf6310-cfc4-4cb4-966e-8561b3880e368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-385-256068703852530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-385-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-385-95) 30 blister pack2018-08-092026-11-30NoNoCurrent
60687-385-95606870385951 in 1 BLISTER PACKHistorical