colesevelam hcl

Generic: colesevelam hcl

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

Drug Facts

Product Profile

Brand Name colesevelam hcl
Generic Name colesevelam hcl
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 50090-4371
Product ID 50090-4371_7b5ac751-04b4-4f79-8ccb-6423929d7339
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209038
Listing Expiration 2026-12-31
Marketing Start 2018-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904371
Hyphenated Format 50090-4371

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 hcl (source: ndc)
Generic Name colesevelam hcl (source: ndc)
Application Number ANDA209038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0)
source: ndc

Packages (1)

50090-4371-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0)

Ingredients (1)

colesevelam hydrochloride (625 mg/1)

Linked Drug Pages (1)

Colesevelam HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b5ac751-04b4-4f79-8ccb-6423929d7339", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["5eb26657-09cf-4229-a567-1395b58bba6b"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0)", "package_ndc": "50090-4371-0", "marketing_start_date": "20190620"}], "brand_name": "Colesevelam HCL", "product_id": "50090-4371_7b5ac751-04b4-4f79-8ccb-6423929d7339", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "50090-4371", "generic_name": "Colesevelam HCL", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam HCL", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA209038", "marketing_category": "ANDA", "marketing_start_date": "20181006", "listing_expiration_date": "20261231"}