FDA.reportPublic FDA data

Colesevelam hydrochloride

Product NDC
51660-996
Requested package NDC
51660-996-28
11-digit product format
516600996
Labeler code
51660
Product ID
51660-996_036fdbc5-98b7-41bb-9f84-871d980167ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories, Inc.
Application
NDA021176
Marketing category
NDA
Marketing start
2018-05-23
Marketing end
2023-11-30
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
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 packagepackage51660-99651660-996-28DDiscontinued 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 · 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-996-282020-08-14C16284748780-1ab0e2407-3403-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
51660-996-282020-07-22C16284748780-1ab0e2407-3403-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
51660-996-28EA - Each51660-9961ef2a656-3fa7-45d6-a0f5-de9c059801de12018-06-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51660-996-2851660099628180 TABLET, FILM COATED in 1 BOTTLE (51660-996-28) 2018-05-232023-11-30NoNoCurrent