SODIUM PHENYLACETATE and SODIUM BENZOATE
These highlights do not include all the information needed to use SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10% safely and effectively. See full prescribing information for SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10%. SODIUM PHENYLACETATE and SODIUM BENZOATE Injection, for intravenous use Initial U.S. Approval: 1987
Approved
Approval ID
23900799-5137-4084-99e3-98d13389e5fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Woodward Pharma Services LLC
DUNS: 080406260
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 Code69784-811
Application NumberANDA207096
Product Classification
M
Marketing Category
C73584
G
Generic Name
sodium phenylacetate and sodium benzoate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (5)
sodium phenylacetateActive
Quantity: 100 mg in 1 mL
Code: 48N6U1781G
Classification: ACTIB
sodium benzoateActive
Quantity: 100 mg in 1 mL
Code: OJ245FE5EU
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT