Quick answers
- What is Denosumab used for?
- The FDA-approved label (Prolia, Amgen, Inc, June 26, 2026) says: “Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Denosumab have a boxed warning?
- Yes. The FDA label for Prolia has a boxed warning (“WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Denosumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Denosumab been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 21, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Denosumab?
- 10 companies list prescription products of Denosumab in the FDA NDC Directory, including CELLTRION USA, Inc., Fresenius Kabi USA, LLC and Organon LLC.
What Denosumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer …
— FDA label: Prolia, Amgen, Inc, effective June 26, 2026. Read the full label on DailyMed →
The FDA has 18 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
. Read it on the full label →
9 of 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| denosumab 120 mg/1.7 mL injection | Brand: Xgeva | $2,001.52 per mL |
| denosumab 60 mg/mL injection | Brand: Conexxence | $1,740.74 per mL |
| denosumab 60 mg/mL injection | Brand: Jubbonti | $1,537.17 per mL |
| denosumab 60 mg/mL injection | Brand: Prolia | $1,863.22 per mL |
| denosumab 60 mg/mL injection | Brand: Stoboclo | $1,578.06 per mL |
| denosumab 60 mg/mL injection, solution | Brand: Bildyos | $813.05 per mL |
NADAC list of November 4, 2026; these prices took effect between January 7, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- CELLTRION USA, Inc.4 products
- Fresenius Kabi USA, LLC3 products
- Organon LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Biocon Biologics Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Accord BioPharma Inc.2 products
- Amgen, Inc2 products
- Sandoz Inc2 products
- Cordavis Limited1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125320 PROLIA, XGEVA | Amgen | June 1, 2010 | 50, latest June 23, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
| BLA761362 JUBBONTI, WYOST | Sandoz Inc | March 5, 2024 | 3, latest October 23, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
| BLA761392 DENOSUMAB-DSSB, OSPOMYV, XBRYK | Samsung Bioepis Co Ltd | February 13, 2025 | — |
| BLA761398 BOMYNTRA, CONEXXENCE | Fresenius Kabi USA LLC | March 25, 2025 | — |
| BLA761404 OSENVELT, STOBOCLO | Celltrion Inc | February 28, 2025 | 1, latest October 29, 2025 2025: Labeling |
| BLA761424 JUBEREQ, OSVYRTI | Accord Biopharma Inc. | October 29, 2025 | — |
| BLA761436 AUKELSO, BOSAYA | Biocon Biologics Inc | September 16, 2025 | — |
| BLA761439 ENOBY, XTRENBO | Hikma Pharmaceuticals USA Inc | September 26, 2025 | — |
| BLA761444 BILDYOS, BILPREVDA | Shanghai Henlius Biotech | August 29, 2025 | — |
| BLA761456 BONCRESA | Amneal Pharms LLC | December 19, 2025 | — |
| BLA761457 OZILTUS | Amneal Pharms LLC | December 19, 2025 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 21, 2025 · Class II · Ongoing · D-0538-2025
CGMP Deviations; potential temperature excursions due to transit delays
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21 — Mckesson Medical-Surgical Inc. Corporate Office
-
September 17, 2013 · Class II · Terminated · D-66318-001
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UP — Amgen, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 993452, 993456, 1046398, 1046402, 2715386, 2715393, 2717531, 2717538, 2717542, 2717549 … (+10) |
|---|---|
| SPL set ID of the quoted label | 49e5afe9-a0c7-40c4-af9f-f287a80c5c88 |
| FDA labels (SPL) | 18 |
| FDA applications | BLA125320, BLA761362, BLA761392, BLA761398, BLA761404, BLA761424, BLA761436, BLA761439, BLA761444, BLA761456, BLA761457 |
| Active ingredients (FDA) | DENOSUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prolia, Amgen, Inc, effective June 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →