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 SUSPENSION
Routes
ORAL
Active Ingredients

colestipol hydrochloride 5 g/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-5213
Product ID 0115-5213_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077277
Listing Expiration 2026-12-31
Marketing Start 2006-05-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01155213
Hyphenated Format 0115-5213

Supplemental Identifiers

RxCUI
1048450
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 ANDA077277 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 g/1
source: ndc
Packaging
  • 100 SUSPENSION in 1 BOTTLE (0115-5213-02)
source: ndc

Packages (1)

0115-5213-02 100 SUSPENSION in 1 BOTTLE (0115-5213-02)

Ingredients (1)

colestipol hydrochloride (5 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": "78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06", "openfda": {"unii": ["X7D10K905G"], "rxcui": ["1048450"], "spl_set_id": ["839354bd-cbac-4d18-8c02-b1b93766af38"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 SUSPENSION in 1 BOTTLE (0115-5213-02)", "package_ndc": "0115-5213-02", "marketing_start_date": "20060502"}], "brand_name": "COLESTIPOL HYDROCHLORIDE", "product_id": "0115-5213_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06", "dosage_form": "SUSPENSION", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "0115-5213", "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": "5 g/1"}], "application_number": "ANDA077277", "marketing_category": "ANDA", "marketing_start_date": "20060502", "listing_expiration_date": "20261231"}