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 FOR SUSPENSION
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 3.75 g/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0935
Product ID 0713-0935_2a324e3d-e3ac-c310-e063-6394a90a0950
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022362
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 07130935
Hyphenated Format 0713-0935

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 NDA022362 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 g/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (0713-0935-30) / 1 FOR SUSPENSION in 1 PACKET
source: ndc

Packages (1)

0713-0935-30 30 PACKET in 1 CARTON (0713-0935-30) / 1 FOR SUSPENSION in 1 PACKET

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": "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": "30 PACKET in 1 CARTON (0713-0935-30)  / 1 FOR SUSPENSION in 1 PACKET", "package_ndc": "0713-0935-30", "marketing_start_date": "20220801"}], "brand_name": "COLESEVELAM HYDROCHLORIDE", "product_id": "0713-0935_2a324e3d-e3ac-c310-e063-6394a90a0950", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "0713-0935", "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": "3.75 g/1"}], "application_number": "NDA022362", "marketing_category": "NDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}