colesevelam

Generic: colesevelam

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

colesevelam hydrochloride 625 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-619
Product ID 68382-619_bf6a10ac-0317-4804-a504-cd00e522dc65
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 68382619
Hyphenated Format 68382-619

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, FILM COATED in 1 BOTTLE (68382-619-10)
  • 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28)
  • 10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)
source: ndc

Packages (3)

68382-619-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) 68382-619-28 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28) 68382-619-77 10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)

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": "bf6a10ac-0317-4804-a504-cd00e522dc65", "openfda": {"unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["6a26e745-7e38-4af0-9bcc-566b2812df75"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10)", "package_ndc": "68382-619-10", "marketing_start_date": "20191011"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28)", "package_ndc": "68382-619-28", "marketing_start_date": "20191011"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-619-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)", "package_ndc": "68382-619-77", "marketing_start_date": "20191011"}], "brand_name": "Colesevelam", "product_id": "68382-619_bf6a10ac-0317-4804-a504-cd00e522dc65", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "68382-619", "generic_name": "Colesevelam", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}