colesevelam hcl

Generic: colesevelam hcl

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hcl
Generic Name colesevelam hcl
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-476
Product ID 72789-476_3ba12d53-699b-c57c-e063-6294a90a8071
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 72789476
Hyphenated Format 72789-476

Supplemental Identifiers

RxCUI
866910
UPC
0372789476933
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
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-476-93)
source: ndc

Packages (1)

72789-476-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-476-93)

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": "3ba12d53-699b-c57c-e063-6294a90a8071", "openfda": {"upc": ["0372789476933"], "unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-476-93)", "package_ndc": "72789-476-93", "marketing_start_date": "20250123"}], "brand_name": "Colesevelam HCL", "product_id": "72789-476_3ba12d53-699b-c57c-e063-6294a90a8071", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "72789-476", "generic_name": "Colesevelam HCL", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}