colesevelam

Generic: colesevelam

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam
Generic Name colesevelam
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1368
Product ID 70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207765
Listing Expiration 2026-12-31
Marketing Start 2019-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711368
Hyphenated Format 70771-1368

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 (source: ndc)
Generic Name colesevelam (source: ndc)
Application Number ANDA207765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1368-0)
  • 10 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2)
  • 180 TABLET in 1 BOTTLE (70771-1368-8)
source: ndc

Packages (3)

70771-1368-0 1000 TABLET in 1 BOTTLE (70771-1368-0) 70771-1368-4 10 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2) 70771-1368-8 180 TABLET in 1 BOTTLE (70771-1368-8)

Ingredients (1)

colesevelam hydrochloride (625 mg/1)

Linked Drug Pages (1)

COLESEVELAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["090eabd5-acd3-43ed-a05b-52f1f3773a93"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1368-0)", "package_ndc": "70771-1368-0", "marketing_start_date": "20191011"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1368-4)  / 10 TABLET in 1 BLISTER PACK (70771-1368-2)", "package_ndc": "70771-1368-4", "marketing_start_date": "20191011"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (70771-1368-8)", "package_ndc": "70771-1368-8", "marketing_start_date": "20191011"}], "brand_name": "COLESEVELAM", "product_id": "70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079", "dosage_form": "TABLET", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "70771-1368", "generic_name": "COLESEVELAM", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COLESEVELAM", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA207765", "marketing_category": "ANDA", "marketing_start_date": "20191011", "listing_expiration_date": "20261231"}