FDA.reportPublic FDA data

Colesevelam hydrochloride

Product NDC
51660-995
Requested package NDC
51660-995-30
11-digit product format
516600995
Labeler code
51660
Product ID
51660-995_036fdbc5-98b7-41bb-9f84-871d980167ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ohm Laboratories, Inc.
Application
NDA022362
Marketing category
NDA
Marketing start
2018-07-17
Marketing end
2023-11-30
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
4 g/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51660-99551660-995-30DDiscontinued 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HYDROCHLORIDE1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-995-302020-08-14C16284748780-1ab0e2407-3403-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE TABLETS and COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE TABLETS and COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION . COLESEVELAM HYDROCHLORIDE tablets, for oral use COLESEVELAM HYDROCHLORIDE for oral suspension Initial U.S. Approval: 2000
51660-995-302020-07-22C16284748780-1ab0e2407-3403-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE TABLETS and COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE TABLETS and COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION . COLESEVELAM HYDROCHLORIDE tablets, for oral use COLESEVELAM HYDROCHLORIDE for oral suspension Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-995-30EA - Each51660-99544d4f7d8-e482-4e03-b088-0f097874ec4312018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-995-305166009953030 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2018-07-172023-11-30NoNoCurrent