COLESTIPOL HYDROCHLORIDE
Colestipol Hydrochloride for Oral Suspension, USP (5 grams/packet and 5 grams/scoopful) Rx only
Approved
Approval ID
839354bd-cbac-4d18-8c02-b1b93766af38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
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 Code0115-5212
Application NumberANDA077277
Product Classification
M
Marketing Category
C73584
G
Generic Name
COLESTIPOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (2)
COLESTIPOL HYDROCHLORIDEActive
Quantity: 5 g in 1 1
Code: X7D10K905G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COLESTIPOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-5213
Application NumberANDA077277
Product Classification
M
Marketing Category
C73584
G
Generic Name
COLESTIPOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (2)
COLESTIPOL HYDROCHLORIDEActive
Quantity: 5 g in 1 1
Code: X7D10K905G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT