Sodium Phenylacetate And Sodium Benzoate Injection, Solution, Concentrate
Product Images NDC 70511-101

5 FDA label images from Maia Pharmaceuticals, Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Sodium Phenylacetate And Sodium Benzoate (NDC 70511-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Maia Pharmaceuticals, Inc, 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

Figure 2 (Figure)

Figure 2 (Figure)
An illustration showing the urea cycle and related metabolic pathways involving benzoate and phenylacetate. The diagram depicts conversion steps including enzymes CPS, OTC, ASS, ASL, ARG, and NAGS, highlighting how supplemented arginine enters the cycle and how benzoate and phenylacetate conjugates lead to urine excretion. Key intermediates such as carbamyl phosphate, ornithine, citrulline, argininosuccinate, arginine, and urea are labeled.*
FDA Label Image

Chemical Structure (Structure)

Chemical Structure (Structure)
Chemical structure diagram showing sodium phenylacetate and sodium benzoate. Each structure includes a benzene ring and the corresponding sodium carboxylate groups; sodium phenylacetate has an additional methylene group linking the benzene ring and carboxylate, while sodium benzoate has the carboxylate directly attached to the benzene ring.*
FDA Label Image

Table 1

Table 1
Table titled 'Dosage and Administration' providing dose loading and maintenance information for sodium phenylacetate and sodium benzoate injection with arginine HCl for patients 0 to 20 kg and over 20 kg. It includes dosage details for CPS and OTC deficiency and ASS and ASL deficiency, listing measurements in mL/kg, mg/kg, and g/m². Abbreviations for CPS, OTC, ASS, and ASL are also provided.*
FDA Label Image

Table 3

Table 3
A data table titled 'Baseline Characteristics and Diagnoses of Study Population' summarizing demographic and clinical information for 316 patients. It lists gender distribution, age ranges with means and minimum-maximum values, age groups by days and years, and enzyme deficiencies with counts and percentages. Footnotes define abbreviations for enzyme deficiencies and additional notes on diagnosis categories.*
FDA Label Image

Vial Jan2021

Vial Jan2021
Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10%, 50 mL vial label for intravenous use only. Contains 100 mg/mL each of sodium phenylacetate and sodium benzoate in sterile, non-pyrogenic concentrate. Manufactured for MAIA Pharmaceuticals, Inc., Princeton, NJ, and by Gland Pharma, Ltd., Hyderabad, India. Warning notes administration via central venous catheter only, and dilution requirements before IV use.*

* 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.