Sodium Phenylacetate and Sodium Benzoate
These highlights do not include all the information needed to use SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION safely and effectively. See full prescribing information for SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION. SODIUM PHENYLACETATE and SODIUM BENZOATE injection, for intravenous use Initial U.S. Approval: 1987
Approved
Approval ID
e6788f4e-72bc-481d-e053-2a95a90ad1c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2023
Manufacturers
FDA
FOSUN PHARMA USA INC
DUNS: 080920998
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
NDC Product Code72266-247
Application NumberANDA208521
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 19, 2023
Generic NameSodium Phenylacetate and Sodium Benzoate
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