Ammonul
These highlights do not include all the information needed to use AMMONUL safely and effectively. See full prescribing information for AMMONUL AMMONUL (sodium phenylacetate and sodium benzoate) injection, for intravenous use Initial U.S. Approval: 1987
Approved
Approval ID
d564f2b1-9fc7-4201-8066-d745ac3a671f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2018
Manufacturers
FDA
Ucyclyd Pharma Inc.
DUNS: 150393221
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium phenylacetate and sodium benzoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62592-720
Application NumberNDA020645
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium phenylacetate and sodium benzoate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 12, 2018
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHENYLACETATEActive
Quantity: 100 mg in 1 mL
Code: 48N6U1781G
Classification: ACTIB
SODIUM BENZOATEActive
Quantity: 100 mg in 1 mL
Code: OJ245FE5EU
Classification: ACTIB