FDA.reportPublic FDA data

Colesevelam Hydrochloride

Product NDC
42291-147
Requested package NDC
42291-147-18
11-digit product format
422910147
Labeler code
42291
Product ID
42291-147_d5798ba9-342d-f155-e053-2a95a90a79ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESEVELAM HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA091600
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-14742291-147-18DDiscontinued 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
A091600-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2018-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091600-001AB

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 22:54:322026-06A091600-001COLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2018-05-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091600-001AB1a50c72e98297…

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 HYDROCHLORIDEAmerican Health Packaging87bf6310-cfc4-4cb4-966e-8561b3880e362025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091600
application number: ANDA091600
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCf5306376-e7f2-44ad-8250-635b95428a7c2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091600
application number: ANDA091600

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-147-18EA - Each42291-14703c49a38-a392-4656-9ace-edbf929db27512018-07-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-147-1842291014718180 TABLET, COATED in 1 BOTTLE (42291-147-18) 2018-06-180000-00-00NoNoCurrent