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Approved
Approval ID
b2e04490-ce9f-493c-ab25-2f53f97969cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2011
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 and electrolytes
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0054
Application NumberNDA019011
Product Classification
M
Marketing Category
C73594
G
Generic Name
PEG-3350 and electrolytes
Product Specifications
Route of AdministrationORAL, NASOGASTRIC
Effective DateAugust 2, 2011
FDA Product Classification
INGREDIENTS (6)
SODIUM BICARBONATEActive
Quantity: 6.74 g in 2 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 2 L
Code: 36KCS0R750
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.86 g in 2 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 2 L
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 2 L
Code: G2M7P15E5P
Classification: ACTIB