colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-385
Product ID 60687-385_45381a76-f843-d419-e063-6294a90a83de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091600
Marketing Start 2018-08-09
Marketing End 2026-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687385
Hyphenated Format 60687-385

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 hydrochloride (source: ndc)
Generic Name colesevelam hydrochloride (source: ndc)
Application Number ANDA091600 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-385-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-385-95)
source: ndc

Packages (1)

60687-385-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-385-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-385-95)

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": "45381a76-f843-d419-e063-6294a90a83de", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["87bf6310-cfc4-4cb4-966e-8561b3880e36"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-385-25)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-385-95)", "package_ndc": "60687-385-25", "marketing_end_date": "20261130", "marketing_start_date": "20180809"}], "brand_name": "Colesevelam Hydrochloride", "product_id": "60687-385_45381a76-f843-d419-e063-6294a90a83de", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "60687-385", "generic_name": "Colesevelam Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam Hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA091600", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20180809"}