Prolia Injection
Product Images NDC 55513-710

9 FDA label images from Amgen, Inc · 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 Prolia (NDC 55513-710). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amgen, Inc, 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

Plunger, Safety Guard, Window, Needle Cap, Finger Grip (Prolia 01)

Plunger, Safety Guard, Window, Needle Cap, Finger Grip (Prolia 01)
An instructional illustration of a prefilled syringe for Prolia (denosumab) 60 mg/mL subcutaneous injection. The diagram labels parts of the syringe including the plunger, safety guard (green plastic), finger grip (clear plastic), window, and needle cap (gray rubber).*
FDA Label Image

Step 1: Remove Grey Needle Cap (Prolia 02)

Step 1: Remove Grey Needle Cap (Prolia 02)
An instructional illustration showing a hand holding a prefilled syringe and another hand removing or placing the cap on the syringe needle, indicated by an arrow pointing toward the syringe. The image demonstrates part of the preparation process for a subcutaneous injection.*
FDA Label Image
Choose An Injection Site.  The Recommended Injection Sites For Prolia Include: The Upper Arm Or The Upper Thigh Or The Abdomen. (Prolia 03)
Instructional illustration showing the proper subcutaneous injection site on the upper thigh. A person is depicted with one hand holding the skin on the upper thigh and the other hand administering an injection at the site.*
FDA Label Image

Insert Needle And Inject All The Liquid Subcutaneously. Do Not Administer Into Muscle Or Blood Vessel. (Prolia 04)

Insert Needle And Inject All The Liquid Subcutaneously.  Do Not Administer Into Muscle Or Blood Vessel. (Prolia 04)
An illustration showing a side view of a person with labeled injection sites for subcutaneous administration: the upper arm and the abdomen. The figure highlights typical areas for subcutaneous injections such as those used for Prolia injection.*
FDA Label Image

Hold Clear Finger Grip. (Prolia 05)

Hold Clear Finger Grip. (Prolia 05)
Illustration showing the administration of a subcutaneous injection using a syringe. The image depicts one hand holding the syringe and the other pinching the skin to prepare the injection site, demonstrating the proper technique for subcutaneous injection.*
FDA Label Image

Gently Slide Green Safety Guard Over Needle And Lock Securely In Place. Do Not Grip Green Safety Guard Too Firmly When Sliding Over Needle. (Prolia 06)

Gently Slide Green Safety Guard Over Needle And Lock Securely In Place.  Do Not Grip Green Safety Guard Too Firmly When Sliding Over Needle. (Prolia 06)
An instructional illustration showing a hand holding a prefilled syringe for subcutaneous injection. The syringe is oriented horizontally with the needle to the right, demonstrating the proper grip and preparation for administration.*
FDA Label Image

Figure 1. Cumulative Incidence Of Hip Fractures Over 3 Years (Prolia 07)

Figure 1. Cumulative Incidence Of Hip Fractures Over 3 Years (Prolia 07)
An instructional black-and-white illustration showing a hand holding a syringe with a needle cap. The image depicts how to hold the Prolia prefilled syringe for subcutaneous injection of denosumab 60 mg/mL by Amgen, Inc.*
FDA Label Image

Prolia 08

Prolia 08
A line graph comparing patient hip fracture incidence (%) over 36 study months between Prolia (denosumab) injection and placebo groups. The graph shows two lines: one solid line representing Prolia and one dashed line for placebo, with the placebo group displaying a higher incidence of hip fractures over time.*
FDA Label Image

Principal Display Panel1 X 60 mg Single Use Prefilled Syringendc 55513-710-01amgen®prolia®(denosumab)60 mg/ml60 mg/ml Injection – For Subcutaneous Use Only.single Use Prefilled Syringe. Discard Unused Portion.sterile Solution – No Preservative.rx Onlyrefrigerate At 2° To 8°c (36° To 46°f). Do Not Freeze. Avoid Excessive Shaking. Protect From Direct Light And Heat.this Product Contains Dry Natural Rubber.manufactured By: Amgen Inc., Thousand Oaks, Ca 91320-1799 (Prolia 09)

Principal Display Panel1 X 60 mg Single Use Prefilled Syringendc 55513-710-01amgen®prolia®(denosumab)60 mg/ml60 mg/ml Injection – For Subcutaneous Use Only.single Use Prefilled Syringe.  Discard Unused Portion.sterile Solution – No Preservative.rx Onlyrefrigerate At 2° To 8°c (36° To 46°f). Do Not Freeze. Avoid Excessive Shaking. Protect From Direct Light And Heat.this Product Contains Dry Natural Rubber.manufactured By: Amgen Inc., Thousand Oaks, Ca 91320-1799 (Prolia 09)
Prolia 60 mg/mL injection in a single-dose prefilled syringe for subcutaneous use by Amgen, Inc. The label highlights the 60 mg/mL strength and includes storage instructions and warnings about preservatives and handling. The product NDC 55513-710-01 is displayed.*

* 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.