colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7604
Product ID 50090-7604_1f95ff46-b4bf-42d3-b39b-b7221c7e07da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209946
Listing Expiration 2026-12-31
Marketing Start 2020-10-19

Pharmacologic Class

Classes
bile acid sequestrant [epc] bile-acid binding activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907604
Hyphenated Format 50090-7604

Supplemental Identifiers

RxCUI
866910
UNII
P4SG24WI5Q

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name colesevelam hydrochloride (source: ndc)
Generic Name colesevelam hydrochloride (source: ndc)
Application Number ANDA209946 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (50090-7604-0)
source: ndc

Packages (1)

50090-7604-0 90 TABLET in 1 BOTTLE (50090-7604-0)

Ingredients (1)

colesevelam hydrochloride (625 mg/1)

Linked Drug Pages (1)

Colesevelam hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1f95ff46-b4bf-42d3-b39b-b7221c7e07da", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["b48a7426-b513-4790-99a4-4f07d83318d7"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-7604-0)", "package_ndc": "50090-7604-0", "marketing_start_date": "20250716"}], "brand_name": "Colesevelam hydrochloride", "product_id": "50090-7604_1f95ff46-b4bf-42d3-b39b-b7221c7e07da", "dosage_form": "TABLET", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "50090-7604", "generic_name": "Colesevelam hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA209946", "marketing_category": "ANDA", "marketing_start_date": "20201019", "listing_expiration_date": "20261231"}