FDA.reportPublic FDA data

Colesevelam HCL

Product NDC
50090-4371
11-digit product format
500904371
Labeler code
50090
Product ID
50090-4371_7b5ac751-04b4-4f79-8ccb-6423929d7339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4371-02023-02-07C16284748780-1f386c649-d0da-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE TABLETS. COLESEVELAM HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000
50090-4371-02023-01-30C16284748780-1f386c649-d0da-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE TABLETS. COLESEVELAM HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4371-0Colesevelam HCL90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4371-0EA - Each50090-4371a8a80bd0-f310-4608-b391-52b47a65e27812022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4371COLESEVELAM HCL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20230208_5eb26657-09cf-4229-a567-1395b58bba6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN5eb26657-09cf-4229-a567-1395b58bba6b10
866910colesevelam hydrochloride 625 MG Oral TabletSCD5eb26657-09cf-4229-a567-1395b58bba6b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4371-05009043710090 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0) 2019-06-200000-00-00NoNoCurrent