FDA.reportPublic FDA data

Welchol

Product NDC
0713-0880
11-digit product format
007130880
Labeler code
0713
Product ID
0713-0880_285004c5-f33a-aaa1-e063-6394a90aac01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA022362
Marketing category
NDA
Marketing start
2022-09-01
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
Welchol
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP4SG24WI5Q
Rxcui866905, 866907, 866910, 866912

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
0713-0880-30Welchol30 in 1 CARTONFOR SUSPENSION303
0713-0880-30Welchol1 in 1 PACKETFOR SUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0880-30EA - Each0713-0880d1679a8f-b070-4b33-b97a-63227c0b77b612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0880WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20241204_89cbd0a3-2d1b-41db-8c97-35ec67b7b09f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSN89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866910colesevelam HCl 625 MG Oral TabletPSN89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866907Welchol 3.75 GM Powder for Oral SuspensionPSN89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866912Welchol 625 MG Oral TabletPSN89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866907colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]SBD89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBD89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCD89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866910colesevelam hydrochloride 625 MG Oral TabletSCD89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSY89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866907Welchol 3.75 GM Powder for Oral SuspensionSY89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866907Welchol 3750 MG Powder for Oral SuspensionSY89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3
866912Welchol 625 MG Oral TabletSY89cbd0a3-2d1b-41db-8c97-35ec67b7b09f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0880-300071308803030 PACKET in 1 CARTON (0713-0880-30) / 1 FOR SUSPENSION in 1 PACKET30 packet2022-09-010000-00-00NoNoCurrent