colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 3.75 g/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1864
Product ID 0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212886
Listing Expiration 2026-12-31
Marketing Start 2023-01-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151864
Hyphenated Format 0115-1864

Supplemental Identifiers

RxCUI
866905
UPC
0301151864306 0301151864184
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 ANDA212886 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 g/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30)
source: ndc

Packages (1)

0115-1864-18 30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30)

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": "83f79a9e-7658-4d89-a3aa-8c5ee39ac846", "openfda": {"upc": ["0301151864306", "0301151864184"], "unii": ["P4SG24WI5Q"], "rxcui": ["866905"], "spl_set_id": ["f33fbf30-2486-49a7-bbe8-0ddfb4b9b786"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (0115-1864-18)  / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30)", "package_ndc": "0115-1864-18", "marketing_start_date": "20230120"}], "brand_name": "Colesevelam hydrochloride", "product_id": "0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "0115-1864", "generic_name": "Colesevelam hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "3.75 g/1"}], "application_number": "ANDA212886", "marketing_category": "ANDA", "marketing_start_date": "20230120", "listing_expiration_date": "20261231"}