Azacitidine Injection, Powder, Lyophilized, For Solution
Product Images NDC 58458-002

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Azacitidine (NDC 58458-002). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Reliance Life Sciences Private Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Table 3 (3)

A table outlining the suspension stability and storage timelines for diluent water used with Azacitidine injection. It specifies storage conditions and durations for sterile water for injection at room temperature (25°C/77°F) and cold (2°C to 8°C/36°F to 46°F) conditions.*

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Aza Label (Aza 100mg Label 12000xxxxx V00)

Azacitidine for Injection 100 mg vial label from Reliance Life Sciences Private Limited. The label states the product is a sterile single-dose vial containing azacitidine 100 mg and mannitol USP 100 mg, for subcutaneous and intravenous use only. It includes storage instructions at 25°C with tolerances and advises discarding unused portions. The label displays the NDC 58458-002-02 and manufacturer details in Maharashtra, India.*

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Aza Carton (Azacitidine 100mg Carton 12000xxxxx V00 Revised)

Flat packaging label for Azacitidine for Injection, 100 mg/vial, a single-dose vial. The label states the product is for subcutaneous and intravenous use only and is Rx only. It is manufactured by Reliance Life Sciences Private Limited. Storage instructions and active ingredient details are also present.*

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Graph 1 (Graph 1)

A Kaplan-Meier survival curve plot showing the proportion surviving over time in months from randomization, comparing azacitidine (AZA) to conventional care regimens (CCR). The chart includes risk numbers at various time points and statistical data such as hazard ratio and confidence interval.*

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Structure (Structure)

Chemical structure diagram of Azacitidine, showing its molecular arrangement with nitrogen-containing heterocyclic ring and hydroxyl groups in the ribose sugar moiety.*

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Table 1 (Table 1)

A data table titled 'Nadir Counts' showing relationships between absolute neutrophil count (ANC) and platelet counts with the percentage dose to be administered next. The table categorizes ANC values and corresponding platelet ranges, indicating dose adjustments of 50%, 67%, and 100% based on counts.*

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Table 2 (Table 2)

A table presenting data on bone marrow biopsy cellularity and the percentage decrease in white blood cell (WBC) or platelet nadir from baseline. It categorizes cellularity at biopsy into ranges of 30-60%, 15-30%, and less than 15%, alongside corresponding percentages for the dose in the next course based on WBC or platelet nadir decrease in specified ranges.*

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Table 4 (Table 4)

A data table comparing demographic and clinical characteristics between Azacitidine and Observation groups in a clinical study. It includes gender, race, age, adjudicated MDS diagnosis at study entry, and transfusion product usage in the 3 months before study entry, with counts and percentages for each category.*

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Table 5 (Table 5)

A data table presenting response criteria for different conditions (RA, RA/RS, RAEB, RAEB-T, CMMoL) measured by marrow and peripheral blood parameters. It details complete and partial response definitions, including blast counts, blood cell levels, and dyspoiesis status.*

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Table 6 1 (Table 6 1)

Table listing the most frequently observed adverse reactions (≥5%) in patients treated with Azacitidine, with numbers and percentages of patients experiencing various blood, lymphatic, and gastrointestinal disorders. It compares any grade versus Grade 3/4 reactions for Azacitidine-treated patients and a best supportive care group.*

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Table 6 3 (Table 6 2)

A data table listing various adverse conditions reported during treatment, categorized into general disorders, infections, investigations, metabolism and nutrition disorders, nervous system disorders, psychiatric disorders, and renal and urinary disorders. It includes events like fatigue, injection site reactions, nervous system symptoms, and psychiatric effects, with numerical frequencies and percentages across several columns.*

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Table 62 (Table 6 3)

A data table presenting incidence counts and percentages of various adverse events categorized by body system, including respiratory, thoracic and mediastinal disorders; skin and subcutaneous tissue disorders; and vascular disorders. Specific adverse events listed include dyspnea, pharyngolaryngeal pain, erythema, petechiae, pruritus, rash, and hypertension, with corresponding numerical data for each.*

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Table 6 (Table 6)

A table presenting response data for Azacitidine injection, lyophilized powder. The table compares overall, complete, and partial response rates before crossover, including numerical counts, percentages, and P values for statistical significance.*

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Table 7 (Table 7)

A data table comparing efficacy parameters between Azacitidine plus Best Supportive Care (BSC) and Conventional Care Regimens groups, including the number and percentage of patients who were transfusion dependent at baseline who became transfusion independent during treatment, and conversely, patients who were transfusion independent at baseline who became transfusion dependent on treatment.*

* 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.