FDA.reportPublic FDA data

Welchol

Product NDC
65597-903
11-digit product format
655970903
Labeler code
65597
Product ID
65597-903_ccd182d4-5850-404f-8036-d5d49367b8a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA022362
Marketing category
NDA
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
2 g/1
Pharmacologic classes
Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65597-903DDiscontinued by firm2026-07-31
excluded packagepackage65597-90365597-903-60DDiscontinued by firm2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022362-001WELCHOLCOLESEVELAM HYDROCHLORIDE1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02
N022362-002WELCHOLCOLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022362-002AB

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 22:54:322026-06N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02a50c72e98297…
2026-08-01 22:54:322026-06N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022362-002AB1a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.]17
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65597-903WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION WELCHOL (COLESEVELAM HYDROCHLORIDE) BAR, CHEWABLE [DAIICHI SANKYO INC.]35Legacy NDC20220617_4a06d3b2-7229-4398-baba-5d0a72f63821.zip