colesevelam hydrochloride

Generic: colesevelam hydrochloride

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colesevelam hydrochloride
Generic Name colesevelam hydrochloride
Labeler cranbury pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colesevelam hydrochloride 625 mg/1

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-190
Product ID 27808-190_47df1b20-2cfd-483e-94cc-232339869d17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209946
Listing Expiration 2026-12-31
Marketing Start 2020-10-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808190
Hyphenated Format 27808-190

Supplemental Identifiers

RxCUI
866910
UPC
0327808190017
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 ANDA209946 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (27808-190-01)
source: ndc

Packages (1)

27808-190-01 180 TABLET in 1 BOTTLE (27808-190-01)

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": "47df1b20-2cfd-483e-94cc-232339869d17", "openfda": {"upc": ["0327808190017"], "unii": ["P4SG24WI5Q"], "rxcui": ["866910"], "spl_set_id": ["5e50cc0c-03bc-444b-9d15-ea112bc0f91c"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (27808-190-01)", "package_ndc": "27808-190-01", "marketing_start_date": "20201019"}], "brand_name": "Colesevelam hydrochloride", "product_id": "27808-190_47df1b20-2cfd-483e-94cc-232339869d17", "dosage_form": "TABLET", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "27808-190", "generic_name": "Colesevelam hydrochloride", "labeler_name": "Cranbury Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colesevelam hydrochloride", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA209946", "marketing_category": "ANDA", "marketing_start_date": "20201019", "listing_expiration_date": "20261231"}