colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler cosette pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0936
Product ID 0713-0936_2a324e3d-e3ac-c310-e063-6394a90a0950
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021176
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130936
Hyphenated Format 0713-0936

Supplemental Identifiers

RxCUI
866905 866910
UPC
0307130935302 0307130936811
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 NDA021176 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81)
source: ndc

Packages (1)

0713-0936-81 180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81)

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": "2a324e3d-e3ac-c310-e063-6394a90a0950", "openfda": {"upc": ["0307130935302", "0307130936811"], "unii": ["P4SG24WI5Q"], "rxcui": ["866905", "866910"], "spl_set_id": ["15ceb7db-ef59-4182-99b6-09b6c3c5430a"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81)", "package_ndc": "0713-0936-81", "marketing_start_date": "20220801"}], "brand_name": "COLESEVELAM HYDROCHLORIDE", "product_id": "0713-0936_2a324e3d-e3ac-c310-e063-6394a90a0950", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "0713-0936", "generic_name": "COLESEVELAM HYDROCHLORIDE", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COLESEVELAM HYDROCHLORIDE", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "NDA021176", "marketing_category": "NDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}