colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler ascend laboratories, llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 3.75 g/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-523
Product ID 67877-523_28be90eb-5090-4aba-ae6e-8a4332ccfbe2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210316
Listing Expiration 2026-12-31
Marketing Start 2019-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877523
Hyphenated Format 67877-523

Supplemental Identifiers

RxCUI
866905
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 ANDA210316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 g/1
source: ndc
Packaging
  • 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)
source: ndc

Packages (1)

67877-523-30 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)

Ingredients (1)

colesevelam hydrochloride (3.75 g/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": "28be90eb-5090-4aba-ae6e-8a4332ccfbe2", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866905"], "spl_set_id": ["dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)", "package_ndc": "67877-523-30", "marketing_start_date": "20190509"}], "brand_name": "Colesevelam hydrochloride", "product_id": "67877-523_28be90eb-5090-4aba-ae6e-8a4332ccfbe2", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "67877-523", "generic_name": "Colesevelam hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "3.75 g/1"}], "application_number": "ANDA210316", "marketing_category": "ANDA", "marketing_start_date": "20190509", "listing_expiration_date": "20261231"}