NuLYTELY
These highlights do not include all the information needed to use NuLYTELY safely and effectively. See full prescribing information for NuLYTELY. NuLYTELY (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) Initial U.S. Approval: 1991
Approved
Approval ID
e7cf708c-937e-4aae-ab0a-0361c144a256
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2022
Manufacturers
FDA
Braintree Laboratories, Inc.
DUNS: 107904591
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, sodium bicarbonate and potassium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52268-302
Application NumberNDA019797
Product Classification
M
Marketing Category
C73594
G
Generic Name
polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2022
FDA Product Classification
INGREDIENTS (4)
POLYETHYLENE GLYCOL 3350Active
Quantity: 420 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 5.72 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 11.2 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.48 g in 4 L
Code: 660YQ98I10
Classification: ACTIM