FDA.reportPublic FDA data

COLESEVELAM HYDROCHLORIDE

Product NDC
0713-0936
11-digit product format
007130936
Labeler code
0713
Product ID
0713-0936_2a324e3d-e3ac-c310-e063-6394a90a0950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESEVELAM HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA021176
Marketing category
NDA
Marketing start
2022-08-01
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP4SG24WI5Q
Rxcui866905, 866910

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
0713-0936-81COLESEVELAM HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0936-81EA - Each0713-09365a4f812a-5139-4380-bf1b-a09f91d2e5c212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0936COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED COLESEVELAM HYDROCHLORIDE FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20241228_15ceb7db-ef59-4182-99b6-09b6c3c5430a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSN15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866910colesevelam HCl 625 MG Oral TabletPSN15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCD15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866910colesevelam hydrochloride 625 MG Oral TabletSCD15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSY15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866910colesevelam HCl 625 MG Oral TabletPSN0127afae-8d8d-43f2-97f9-4f99f6947e811
866910colesevelam HCl 625 MG Oral TabletPSN40d66c9d-ff51-4353-8133-ae3a8eb4f7131
866910colesevelam hydrochloride 625 MG Oral TabletSCD0127afae-8d8d-43f2-97f9-4f99f6947e811
866910colesevelam hydrochloride 625 MG Oral TabletSCD40d66c9d-ff51-4353-8133-ae3a8eb4f7131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0936-8100713093681180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81) 2022-08-010000-00-00NoNoCurrent