FDA.reportPublic FDA data

Colesevelam Hydrochloride

Product NDC
51407-159
Requested package NDC
51407-159-18
11-digit product format
514070159
Labeler code
51407
Product ID
51407-159_f205b04d-16dc-02ba-e053-2a95a90a0108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA210889
Marketing category
ANDA
Marketing start
2018-10-05
Marketing end
2023-01-31
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 packagepackage51407-15951407-159-18DDiscontinued 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
A210889-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2018-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210889-001AB

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 22:54:322026-06A210889-001COLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2018-10-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210889-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEDr.Reddys Laboratories Inc28701657-640a-67d6-e56f-cf5c672c6e2a2023-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210889
application number: ANDA210889

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-159-18EA - Each51407-159d0a3fd6b-7618-4869-912a-ed285c04c24912019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-159-1851407015918180 TABLET in 1 BOTTLE (51407-159-18) 180 tablet2018-10-302023-01-31NoNoCurrent