Colesevelam Hydrochloride
Initial U.S. Approval: 2000
Approved
Approval ID
28701657-640a-67d6-e56f-cf5c672c6e2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2023
Manufacturers
FDA
Dr.Reddys Laboratories Inc
DUNS: 802315887
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colesevelam Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-230
Application NumberANDA210889
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colesevelam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (12)
Diacetylated MonoglyceridesInactive
Code: 5Z17386USF
Classification: IACT
Hypromellose 2910 (5 Mpa.S)Inactive
Code: R75537T0T4
Classification: IACT
Colesevelam HydrochlorideActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT