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

View Photos of Packaging, Regulatory Labels, and Product Appearance

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)
A data table titled 'Suspension Stability Storage timelines' showing storage temperature and duration details for diluents used with the drug. It compares room temperature and cold storage conditions for sterile water for injection, USP, specifying maximum storage times at each temperature range.*
FDA Label Image

Carton (Carton To Upload)

Carton (Carton To Upload)
Packaging label for Azacitidine for Injection 100 mg/vial, a single-dose vial in lyophilized powder form for subcutaneous and intravenous use. The label displays the brand name Somerset Therapeutics LLC as the labeler and includes storage instructions, dosage form, and NDC number 70069-857-01. The design features a gradient red/pink background with the Somerset Therapeutics LLC logo and barcode.*
FDA Label Image

Graph 1 (Graph 1)

Graph 1 (Graph 1)
A Kaplan-Meier survival curve chart comparing the proportion surviving over time (months) from randomization between azacitidine (AZA) and conventional care regimens (CCR). The graph includes hazard ratio and confidence interval data along with the number of patients at risk at different time points for each group.*
FDA Label Image

Vial Label (Label To Upload)

Vial Label (Label To Upload)
Label for Azacitidine injection powder, lyophilized, 100 mg per vial. The label specifies it is for subcutaneous and intravenous use, single-dose vial, manufactured for Somerset Therapeutics LLC, with storage instructions and a barcode. The label design includes a gradient pink background with black and red text.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of azacitidine showing its molecular arrangement with nitrogen, oxygen, and hydroxyl groups as part of its nucleoside analog structure.*
FDA Label Image

Table 1 (Table 1)

Table 1 (Table 1)
A data table presenting nadir counts of ANC (x10^9/L) and platelets (x10^9/L) related to the percentage dose of a drug to be used in the next course. The table shows three ranges of ANC and platelets along with corresponding percentage doses for future treatment courses.*
FDA Label Image

Table 2 (Table 2)

Table 2 (Table 2)
A data table showing bone marrow biopsy cellularity at the time of nadir and its relation to WBC or platelet nadir percentage decrease from baseline and the corresponding dose percentage for the next course. The table categorizes values based on biopsy cellularity percentages (>75%, 50-75%, 30-60%, 15-30%, and <15%) and WBC or platelet nadir decreases (less than 15%, 15-30%, and 30-60%), providing dose adjustment percentages of 100%, 75%, 50%, and 33% accordingly.*
FDA Label Image

Table 5 (Table 5)

Table 5 (Table 5)
A data table summarizing criteria for Complete Response (CR) and Partial Response (PR) lasting 4 or more weeks across different conditions (RA, RA RS, RAEB, RAEB-T, CMMoL). It includes marrow and peripheral blood parameters such as blast percentages, blood cell counts, and presence of dyspoiesis for bone marrow and peripheral circulation.*
FDA Label Image

Table 7 (Table 7)

Table 7 (Table 7)
A data table comparing efficacy parameters between Azacitidine plus BSC and Conventional Care Regimens, showing the number and percent of patients who were transfusion dependent or independent at baseline and their transfusion status changes during treatment, including confidence intervals for each group.*

* 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.