COLESTIPOL HYDROCHLORIDE
Colestipol Hydrochloride Tablets, USP (1 gram) Rx only
Approved
Approval ID
8b9cadd9-7cdb-4279-9171-2df25bbbd238
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2021
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COLESTIPOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-2142
Application NumberANDA077510
Product Classification
M
Marketing Category
C73584
G
Generic Name
COLESTIPOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2023
FDA Product Classification
INGREDIENTS (8)
COLESTIPOL HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: X7D10K905G
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLACEFATEInactive
Code: F2O5O2OI9F
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT