Acetylcysteine Injection, Solution
Product Images NDC 63323-963

6 FDA label images from Fresenius Kabi Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Acetylcysteine (NDC 63323-963). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, 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 1 (Ace0v 0000 01)

Figure 1 (Ace0v 0000 01)
A line graph depicting plasma acetylcysteine concentration over time after ingestion. The x-axis represents hours after ingestion, ranging from 0 to 10 hours, and the y-axis shows plasma concentration in micrograms per milliliter, spanning from 0 to 4000. The graph includes multiple lines illustrating different pharmacokinetic phases: disposable therapeutic plasma concentration, no hepatotoxic effect, and a threshold of 25%. The chart provides a visual representation of acetylcysteine plasma levels and their changes across time.*
FDA Label Image

Figure 2 (Ace0v 0000 02)

Figure 2 (Ace0v 0000 02)
Flowchart illustrating the clinical decision process for acetaminophen ingestion management, including timing of ingestion, serum level testing, and criteria for acetylcysteine treatment initiation based on plasma level plots relative to a treatment line on a nomogram.*
FDA Label Image

Figure 3 (Ace0v 0000 03)

Figure 3 (Ace0v 0000 03)
Chemical structure diagram of acetylcysteine, showing its molecular arrangement with labeled atoms and bonds corresponding to the 200 mg/mL intravenous injection formulation by Fresenius Kabi USA, LLC.*
FDA Label Image

Prxlogo (Ace0v 0000 04)

FDA Label Image

Prxvialpdp (Ace0v 0000 05)

Prxvialpdp (Ace0v 0000 05)
Label for Acetylcysteine Injection, 6 grams per 30 mL (200 mg/mL), presented as a single-dose vial. The label includes dilution instructions stating the solution must be further diluted prior to intravenous use. It is marked Rx only and manufactured by Fresenius Kabi USA, LLC.*
FDA Label Image

Prx Ctnpdp (Ace0v 0000 06)

Prx Ctnpdp (Ace0v 0000 06)
Label for Acetylcysteine Injection, 6 grams per 30 mL (200 mg per mL) solution for intravenous use. The label indicates the product comes in 4 single dose vials of 30 mL each. Manufacturer is Fresenius Kabi USA, LLC, with NDC 63323-963.*

* 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.