Kepivance Injection, Powder, Lyophilized, For Solution
Product Images NDC 66658-113

4 FDA label images from Swedish Orphan Biovitrum Ab (publ) · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Kepivance (NDC 66658-113). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Swedish Orphan Biovitrum Ab (publ), 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 (Kep05 0001 01)

Figure 1 (Kep05 0001 01)
Bar chart comparing incidence percentages of different grades (Grade 1 to Grade 4) of an unspecified variable among placebo and Kepivance (palifermin) groups, each with a sample size of 106. The chart visually differentiates incidence levels of each grade for placebo and Kepivance groups.*
FDA Label Image

Figure 2 (Kep05 0001 02)

Figure 2 (Kep05 0001 02)
A vertical stacked bar chart comparing the incidence of adverse event grades (0, 1, 2, 3, 4) across three groups: Placebo, Kepivance® pre-post, and Kepivance® pre-only. Each bar shows the proportion of subjects experiencing each grade level, with sample sizes listed below each group.*
FDA Label Image

Principal Display Panel (6.25 mg/1.2 mL Carton Label)

Principal Display Panel (6.25 mg/1.2 mL Carton Label)
KEPIVANCE (palifermin) 6.25 mg/vial injection, lyophilized powder for solution, packaged in a box labeled for six single-use vials. The label specifies intravenous use, storage instructions, and manufacturer Swedish Orphan Biovitrum AB (publ). The packaging is green with white and yellow text, and includes barcode and lot information areas.*
FDA Label Image

Principal Display Panel (6.25 mg/1.2 mL Carton Label)

Principal Display Panel (6.25 mg/1.2 mL Carton Label)
Packaging label for KEPIVANCE (palifermin) injection, powder, lyophilized, for solution. The label shows a 6.25 mg/vial strength for intravenous use, with a pack configuration of three single-use vials. Manufactured by Swedish Orphan Biovitrum AB (publ), the label includes storage instructions, barcode, and regulatory information on a green background with white and yellow text.*

* 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.