FDA.reportPublic FDA data

Welchol

Product NDC
0713-0879
Requested package NDC
0713-0879-81
11-digit product format
007130879
Labeler code
0713
Product ID
0713-0879_285004c5-f33a-aaa1-e063-6394a90aac01
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
2022-09-01
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0713-08790713-0879-81IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021176-001WELCHOLCOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALABRLD, RS2000-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021176-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021176-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0127afae-8d8d-43f2-97f9-4f99f6947e812023-12-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021176
application number: NDA021176
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions40d66c9d-ff51-4353-8133-ae3a8eb4f7132023-12-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021176
application number: NDA021176

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
0713-0879-81Welchol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0879-81EA - Each0713-08795602cbe1-904a-41ac-8843-172b346762df12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0879WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0879-8100713087981180 TABLET, FILM COATED in 1 BOTTLE (0713-0879-81) 2022-09-010000-00-00NoNoCurrent