colesevelam hydrochloride

Generic: colesevelam hydrochloride

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

Drug Facts

Product Profile

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

colesevelam hydrochloride 625 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-433
Product ID 68462-433_169fb7d2-7872-46a4-99ab-94f46781348f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203480
Listing Expiration 2027-12-31
Marketing Start 2018-05-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462433
Hyphenated Format 68462-433

Supplemental Identifiers

RxCUI
866910
UPC
0368462433188
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 ANDA203480 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)
source: ndc

Packages (2)

68462-433-18 180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18) 68462-433-90 90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)

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": "169fb7d2-7872-46a4-99ab-94f46781348f", "openfda": {"upc": ["0368462433188"], "unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["845b8661-0aa9-418f-a496-df3d7a3130ff"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18)", "package_ndc": "68462-433-18", "marketing_start_date": "20180518"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)", "package_ndc": "68462-433-90", "marketing_start_date": "20180518"}], "brand_name": "colesevelam hydrochloride", "product_id": "68462-433_169fb7d2-7872-46a4-99ab-94f46781348f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "68462-433", "generic_name": "colesevelam hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "colesevelam hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA203480", "marketing_category": "ANDA", "marketing_start_date": "20180518", "listing_expiration_date": "20271231"}