CLENPIQ
These highlights do not include all the information needed to use CLENPIQ safely and effectively. See full prescribing information for CLENPIQ. CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution Initial U.S. Approval: 2012
Approved
Approval ID
e95fff66-4ec0-4001-a727-33e66a5ec7d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2023
Manufacturers
FDA
Ferring Pharmaceuticals Inc.
DUNS: 103722955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55566-6800
Application NumberNDA209589
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (12)
SODIUM PICOSULFATEActive
Quantity: 10 mg in 175 mL
Code: LR57574HN8
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 3.5 g in 175 mL
Code: 3A3U0GI71G
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDActive
Quantity: 12 g in 175 mL
Code: XF417D3PSL
Classification: ACTIB
CRANBERRYInactive
Code: 0MVO31Q3QS
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT