POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
These highlights do not include all the information needed to use PEG-3350 and electrolyte for oral solution safely and effectively. See full prescribing information for PEG-3350 and electrolyte for oral solution. PEG-3350 (236 g) and electrolyte for oral solution, USPInitial U.S. Approval:1984
Approved
Approval ID
29d821ff-389c-41fb-8a27-89bd3f022b82
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-090
Application NumberANDA090231
Product Classification
M
Marketing Category
C73584
G
Generic Name
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (7)
POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 274.31 g
Code: G2M7P15E5P
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.86 g in 274.31 g
Code: 451W47IQ8X
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 274.31 g
Code: 36KCS0R750
Classification: ACTIR
SODIUM BICARBONATEActive
Quantity: 6.74 g in 274.31 g
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 274.31 g
Code: 660YQ98I10
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT