Colestipol Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 825560733

Effective Date

November 18, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Colestipol(5 g in 5 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Mylan Pharmaceuticals Inc.

DUNS Number

618054084

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

59762-0260

Application Number

NDA017563

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 18, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: X7D10K905GClass: ACTIBQuantity: 5 g in 5 g