GoLYTELY
These highlights do not include all the information needed to use GOLYTELY safely and effectively. See full prescribing information for GOLYTELY. GOLYTELY (polyethylene glycol 3350 and electrolytes for oral solution) Initial U.S. Approval: 1984
Approved
Approval ID
57d22b0b-1ae0-4203-babc-f3bac17bd1c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2021
Manufacturers
FDA
Braintree Laboratories, Inc.
DUNS: 107904591
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52268-100
Application NumberNDA019011
Product Classification
M
Marketing Category
C73594
G
Generic Name
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2021
FDA Product Classification
INGREDIENTS (5)
POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 4 L
Code: 36KCS0R750
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.74 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.86 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 4 L
Code: 660YQ98I10
Classification: ACTIB
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52268-700
Application NumberNDA019011
Product Classification
M
Marketing Category
C73594
G
Generic Name
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2021
FDA Product Classification
INGREDIENTS (5)
POLYETHYLENE GLYCOL 3350Active
Quantity: 227.1 g in 1 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.53 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.754 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 21.5 g in 1 L
Code: 36KCS0R750
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.36 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52268-101
Application NumberNDA019011
Product Classification
M
Marketing Category
C73594
G
Generic Name
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEActive
Quantity: 5.86 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 4 L
Code: 36KCS0R750
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.74 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 4 L
Code: 660YQ98I10
Classification: ACTIB