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
9067c301-74f9-457a-9b0f-b7e9b06a3508
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2025
Manufacturers
FDA
Omnivium Pharmaceuticals LLC
DUNS: 117919347
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 Code81665-203
Application NumberANDA207096
Product Classification
M
Marketing Category
C73584
G
Generic Name
sodium phenylacetate and sodium benzoate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 15, 2025
FDA Product Classification
INGREDIENTS (5)
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
sodium phenylacetateActive
Quantity: 100 mg in 1 mL
Code: 48N6U1781G
Classification: ACTIB