Sodium Phenylacetate And Sodium Benzoate Injection
Product Images NDC 70511-102

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Sodium Phenylacetate And Sodium Benzoate (NDC 70511-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Maia Pharmaceuticals, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Carton (Carton Label)

Packaging label for Sodium Phenylacetate and Sodium Benzoate Injection 10%/10%, 20 mL vial, from MAIA Pharmaceuticals. The label displays dosage concentration, instructions for intravenous use only, dilution requirements, storage conditions (20°C to 25°C, with permitted excursions), and warnings about administration through a central venous catheter. Manufactured by Gland Pharma, Hyderabad, India.*

FDA Label Image

Figure 1 (Chemical Structure)

Chemical structure diagrams of the active ingredients Sodium Phenylacetate and Sodium Benzoate, showing their molecular structures with labeled chemical groups.*

FDA Label Image

Figure 2 (Figure 2)

A biochemical pathway diagram illustrating the urea cycle and related metabolic processes. The cycle includes enzymes such as carbamyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase (ARG), and N-acetylglutamate synthetase (NAGS). Metabolites like ammonia (NH4+), glutamine derivatives, and urea precursors are shown, with arrows indicating flow and supplemented arginine and urea excretion pathways.*

FDA Label Image

Table 1 (Table 1 Revised)

A dosage and administration data table for Sodium Phenylacetate and Sodium Benzoate Injection. It details infusion solution components and dosage amounts for different patient populations (0 to 20 kg and over 20 kg), with separate dosing for CPS and OTC deficiency versus ASS and ASL deficiency. Dosages are provided in mL/kg or mL/m2 and mg/kg for Sodium Phenylacetate, Sodium Benzoate, and Arginine HCl.*

FDA Label Image

Table 2 (Table 2)

A data table listing adverse reactions occurring in 3% or more of patients treated with Sodium Phenylacetate and Sodium Benzoate Injection. The table categorizes adverse events by system disorders (e.g., blood, cardiac, gastrointestinal, nervous system) and provides the number and percentage of affected patients out of 316 total.*

FDA Label Image

Table 3 (Table 3)

Data table titled 'Baseline Characteristics and Diagnoses of Study Population' summarizing patient demographics and enzyme deficiencies for 316 patients. It includes gender distribution, age statistics, age group categories, and frequencies of various enzyme deficiencies such as OTC, ASS, CPS, among others, with footnotes explaining abbreviations and additional diagnosis details.*

FDA Label Image

Vial (Vial Label Revised)

Label for Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%, 20 mL vial by MAIA Pharmaceuticals. The label includes dosage information, administration warnings, storage instructions, and manufacturer details. It states the product is for intravenous use only and must be diluted before administration.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.