colestipol hydrochloride

Generic: colestipol hydrochloride

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

Drug Facts

Product Profile

Brand Name colestipol hydrochloride
Generic Name colestipol hydrochloride
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colestipol hydrochloride 1 g/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-395
Product ID 62559-395_f062e9d4-c5ef-411e-8f4a-6deec3ee95c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216517
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559395
Hyphenated Format 62559-395

Supplemental Identifiers

RxCUI
1048445
UPC
0362559395120
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 ANDA216517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12)
source: ndc

Packages (1)

62559-395-12 120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12)

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": "f062e9d4-c5ef-411e-8f4a-6deec3ee95c7", "openfda": {"upc": ["0362559395120"], "unii": ["X7D10K905G"], "rxcui": ["1048445"], "spl_set_id": ["3d380b5e-e346-4a47-ac95-faa37c6f2a51"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12)", "package_ndc": "62559-395-12", "marketing_start_date": "20230515"}], "brand_name": "COLESTIPOL HYDROCHLORIDE", "product_id": "62559-395_f062e9d4-c5ef-411e-8f4a-6deec3ee95c7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "62559-395", "generic_name": "COLESTIPOL HYDROCHLORIDE", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COLESTIPOL HYDROCHLORIDE", "active_ingredients": [{"name": "COLESTIPOL HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA216517", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}