colestipol hydrochloride

Generic: colestipol hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colestipol hydrochloride
Generic Name colestipol hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colestipol hydrochloride 1 g/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-5211
Product ID 0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077510
Listing Expiration 2026-12-31
Marketing Start 2021-08-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01155211
Hyphenated Format 0115-5211

Supplemental Identifiers

RxCUI
1048445
UPC
0301155211168
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 ANDA077510 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)
source: ndc

Packages (2)

0115-5211-02 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02) 0115-5211-16 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)

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": "4ec79132-daa8-4439-bbd2-6f8c8c020e4f", "openfda": {"upc": ["0301155211168"], "unii": ["X7D10K905G"], "rxcui": ["1048445"], "spl_set_id": ["fa6c3e11-84e9-433d-aa74-7cd34336bbed"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02)", "package_ndc": "0115-5211-02", "marketing_start_date": "20210817"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)", "package_ndc": "0115-5211-16", "marketing_start_date": "20210817"}], "brand_name": "COLESTIPOL HYDROCHLORIDE", "product_id": "0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "0115-5211", "generic_name": "COLESTIPOL HYDROCHLORIDE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COLESTIPOL HYDROCHLORIDE", "active_ingredients": [{"name": "COLESTIPOL HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA077510", "marketing_category": "ANDA", "marketing_start_date": "20210817", "listing_expiration_date": "20261231"}