Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution with Flavor pack
Approved
Approval ID
444c83ae-ac3a-467c-be05-e2bcbfbaaba1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2009
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, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-050
Application NumberANDA090019
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2009
FDA Product Classification
INGREDIENTS (8)
POLYETHYLENE GLYCOL 3350Active
Quantity: 420 g in 438.4 g
Code: G2M7P15E5P
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 11.2 g in 438.4 g
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 5.72 g in 438.4 g
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.48 g in 438.4 g
Code: 660YQ98I10
Classification: ACTIB
ALPHA-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT