colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-197
Product ID 33342-197_c2075dd1-e33c-4438-95f8-1897f0e1f61a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204893
Listing Expiration 2026-12-31
Marketing Start 2025-04-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342197
Hyphenated Format 33342-197

Supplemental Identifiers

RxCUI
866910
UPC
0333342197573
UNII
P4SG24WI5Q

Packaging Origin

Original Packager
true

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 ANDA204893 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57)
source: ndc

Packages (1)

33342-197-57 180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57)

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": "c2075dd1-e33c-4438-95f8-1897f0e1f61a", "openfda": {"upc": ["0333342197573"], "unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["c2075dd1-e33c-4438-95f8-1897f0e1f61a"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57)", "package_ndc": "33342-197-57", "marketing_start_date": "20250418"}], "brand_name": "Colesevelam Hydrochloride", "product_id": "33342-197_c2075dd1-e33c-4438-95f8-1897f0e1f61a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "33342-197", "generic_name": "Colesevelam Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam Hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA204893", "marketing_category": "ANDA", "marketing_start_date": "20250418", "listing_expiration_date": "20261231"}