colesevelam hydrochloride

Generic: colesevelam hydrochloride

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

Drug Facts

Product Profile

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

colesevelam hydrochloride 625 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6994
Product ID 50090-6994_d74dadc8-3861-4ff7-92d2-69e983a732e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021176
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906994
Hyphenated Format 50090-6994

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 NDA021176 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-6994-0)
source: ndc

Packages (1)

50090-6994-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-6994-0)

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": "d74dadc8-3861-4ff7-92d2-69e983a732e0", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["40d66c9d-ff51-4353-8133-ae3a8eb4f713"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6994-0)", "package_ndc": "50090-6994-0", "marketing_start_date": "20231227"}], "brand_name": "COLESEVELAM HYDROCHLORIDE", "product_id": "50090-6994_d74dadc8-3861-4ff7-92d2-69e983a732e0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "50090-6994", "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": "NDA021176", "marketing_category": "NDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}