FDA.reportPublic FDA data

Colesevelam HCL

Product NDC
50090-7811
11-digit product format
500907811
Labeler code
50090
Product ID
50090-7811_fc668bf2-580a-4bd9-9649-9538c20745a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209038
Marketing category
ANDA
Marketing start
2018-10-06
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
2026-12-31
Current FDA listing
Yes

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
A209038-001COLESEVELAM 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
A209038-001AB

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 22:54:322026-06A209038-001COLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2018-10-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209038-001AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colesevelam HCLCOLESEVELAM HCLBryant Ranch Prepack5d1b8dfd-cfe7-4c86-9d7b-a709b593acf72026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038
Colesevelam HCLCOLESEVELAM HCLAscend Laboratories, LLC4ffd02a3-86b8-4af7-b539-aa32e38c6b122026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038
Colesevelam HCLCOLESEVELAM HCLA-S Medication Solutions5eb26657-09cf-4229-a567-1395b58bba6b2025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038
Colesevelam HCLCOLESEVELAM HCLA-S Medication Solutions62ea3a03-5cd0-4adc-8464-c7d8b00cd0de2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038
ndc (product): 50090-7811
Colesevelam HCLCOLESEVELAM HCLBryant Ranch Prepack22cf31e6-59fa-40db-a181-2a12afc3af432025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038
Colesevelam HCLCOLESEVELAM HCLPD-Rx Pharmaceuticals, Inc.66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb2025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038
Colesevelam HCLCOLESEVELAM HCLBryant Ranch Prepackffac398c-3eb7-482a-80ce-0ad2cbd2bdca2024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209038
application number: ANDA209038

Additional Listing Data#

Finished product
Yes
Brand name base
Colesevelam HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P4SG24WI5QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866910Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62ea3a03-5cd0-4adc-8464-c7d8b00cd0deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7811-0Colesevelam HCL90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7811-0EA - Each50090-781194a1a1e5-7aa7-4a28-99dd-6bceb3c2dab012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN62ea3a03-5cd0-4adc-8464-c7d8b00cd0de1
866910colesevelam hydrochloride 625 MG Oral TabletSCD62ea3a03-5cd0-4adc-8464-c7d8b00cd0de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7811-05009078110090 TABLET, FILM COATED in 1 BOTTLE (50090-7811-0) 2025-12-05NoNoCurrent