NuLYTELY
NuLYTELY® with Flavor PacksPEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution
Approved
Approval ID
b630fb8f-b6aa-4b94-a93c-d79f1626c05b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
PRODUCT DETAILS
NDC Product Code54868-4233
Application NumberNDA019797
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 11, 2011
Generic NamePEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
INGREDIENTS (9)
POLYETHYLENE GLYCOL 3350Active
Quantity: 210 g in 2 L
Code: G2M7P15E5P
Classification: ACTIB
LEMONInactive
Code: 24RS0A988O
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PINEAPPLEInactive
Code: 2A88ZO081O
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 2.86 g in 2 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.6 g in 2 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.74 g in 2 L
Code: 660YQ98I10
Classification: ACTIB
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
LIMEInactive
Code: C7X2M0VVNH
Classification: IACT