Azacitidine Injection, Powder, Lyophilized, For Solution
Product Images NDC 70069-857

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Azacitidine (NDC 70069-857). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Somerset Therapeutics 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

Table 3 (3)

Table 3 (3)
The text provides information on the suspension stability storage timelines for Dilvent, including the storage temperature duration for Sterile Water for Injection, USP. It states that the storage options are at room temperature (25°C or 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 8 hours. For the cold storage option (2°C to 8°C or 36°F to 46°F), it mentions to store refrigerated for up to 22 hours.*
FDA Label Image

Carton (Carton To Upload)

Carton (Carton To Upload)
This text describes a medication named Azacitidine for Injection, provided in a single-dose vial for subcutaneous and intravenous use only. The vial contains Azacitidine 100 mg and mannitol USP 100 mg. It provides instructions for dosing and administration and specifies to discard any unused portion. The medication should be stored at 25°C with excursions permitted to 15°C to 30°C. The text also includes information on the manufacturer, Somerset Therapeutics LLC and lists specific colors used in the packaging such as Pantone 485 C, Pantone 300 C, and Black 100%.*
FDA Label Image

Graph 1 (Graph 1)

Graph 1 (Graph 1)
This text provides abbreviations and symbols used in a medical or research context. It includes "AZA" for azacitidine, "CCR" for conventional care regimens, "CI" for confidence interval, and "HR" for Hazard Ratio. These terms are typically used in clinical trials, studies, or articles for a more concise and uniform representation of important concepts.*
FDA Label Image

Vial Label (Label To Upload)

Vial Label (Label To Upload)
This is a description of a single-dose vial containing azacitidine 100 mg and mannitol USP 100mg. The vial is 40mm in size and includes dosage information and storage instructions. The product is by Somerset Therapeutics, LLC and has a NDC code of 70069-857-01. It should be kept at a controlled room temperature and out of reach of children.*
FDA Label Image

Structure (Structure)

FDA Label Image

Table 1 (Table 1)

Table 1 (Table 1)
This text appears to be a table showing the Nadir Counts for ANC (Absolute Neutrophil Count) and Platelets, with corresponding dose percentages for the next course of treatment based on the readings. It categorizes the ANC and platelet counts as well as indicates the percentage of the dose to be given based on those counts.*
FDA Label Image

Table 2 (Table 2)

FDA Label Image

Table 5 (Table 5)

FDA Label Image

Table 7 (Table 7)

Table 7 (Table 7)
The text contains information about the efficacy parameter of Azacitidine plus best supportive care (BSC) compared to conventional care regimens. It discusses the transition of patients from being transfusion-dependent at baseline to becoming transfusion-independent on treatment. It includes the number and percent of patients falling into these categories along with corresponding confidence intervals. The criterion for considering a patient transfusion-independent is detailed, based on the absence of RBC transfusions for a specified number of consecutive days during the treatment period. The content sheds light on the impact of the treatment on the transfusion dependency of patients.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.