colesevelam hcl

Generic: colesevelam hcl

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

Drug Facts

Product Profile

Brand Name colesevelam hcl
Generic Name colesevelam hcl
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-506
Product ID 67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e
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 67877506
Hyphenated Format 67877-506

Supplemental Identifiers

RxCUI
866910
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 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
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-506-30)
  • 180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51)
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)
source: ndc

Packages (4)

67877-506-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05) 67877-506-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-506-30) 67877-506-51 180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51) 67877-506-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)

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": "6289ed62-26fb-4c9e-971a-39a5e53c5c2e", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["4ffd02a3-86b8-4af7-b539-aa32e38c6b12"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05)", "package_ndc": "67877-506-05", "marketing_start_date": "20181006"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-506-30)", "package_ndc": "67877-506-30", "marketing_start_date": "20181006"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51)", "package_ndc": "67877-506-51", "marketing_start_date": "20181006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)", "package_ndc": "67877-506-90", "marketing_start_date": "20181006"}], "brand_name": "Colesevelam HCL", "product_id": "67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "67877-506", "generic_name": "Colesevelam HCL", "labeler_name": "Ascend Laboratories, LLC", "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"}