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 useInitial U.S. Approval: 1987
Approved
Approval ID
0f17c50f-3761-4470-bf3b-63837a287b8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1926
Application NumberANDA217526
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium phenylacetate and Sodium benzoate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM BENZOATEActive
Quantity: 100 mg in 1 mL
Code: OJ245FE5EU
Classification: ACTIB
SODIUM PHENYLACETATEActive
Quantity: 100 mg in 1 mL
Code: 48N6U1781G
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT