colestipol hydrochloride

Generic: colestipol hydrochloride

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colestipol hydrochloride
Generic Name colestipol hydrochloride
Labeler edenbridge pharmaceuticals llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colestipol hydrochloride 1 g/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-115
Product ID 42799-115_440d1d49-3eb7-42db-8536-9f0a91c46532
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217667
Listing Expiration 2026-12-31
Marketing Start 2024-11-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42799115
Hyphenated Format 42799-115

Supplemental Identifiers

RxCUI
1048445
UPC
0342799115016
UNII
X7D10K905G

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 colestipol hydrochloride (source: ndc)
Generic Name colestipol hydrochloride (source: ndc)
Application Number ANDA217667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (42799-115-01)
source: ndc

Packages (1)

42799-115-01 120 TABLET in 1 BOTTLE (42799-115-01)

Ingredients (1)

colestipol hydrochloride (1 g/1)

Linked Drug Pages (1)

Colestipol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "440d1d49-3eb7-42db-8536-9f0a91c46532", "openfda": {"upc": ["0342799115016"], "unii": ["X7D10K905G"], "rxcui": ["1048445"], "spl_set_id": ["03ca5800-4211-4383-a332-be88bd9b5304"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (42799-115-01)", "package_ndc": "42799-115-01", "marketing_start_date": "20241126"}], "brand_name": "Colestipol Hydrochloride", "product_id": "42799-115_440d1d49-3eb7-42db-8536-9f0a91c46532", "dosage_form": "TABLET", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "42799-115", "generic_name": "Colestipol Hydrochloride", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colestipol Hydrochloride", "active_ingredients": [{"name": "COLESTIPOL HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA217667", "marketing_category": "ANDA", "marketing_start_date": "20241126", "listing_expiration_date": "20261231"}