Quick answers
- What is Prolia?
- Prolia is a brand name of Denosumab, a prescription medicine. The FDA NDC Directory lists 1 Prolia product in 1 strength and form.
- Who makes Prolia?
- Amgen holds the FDA application for Prolia (BLA125320, approved June 1, 2010).
- Is there a generic or store brand of Prolia?
- Yes. The FDA NDC Directory lists 7 other products with the same active ingredients, strength and form as a Prolia product. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Prolia?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Prolia strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Prolia been recalled?
- FDA enforcement reports list 2 recalls of Prolia products; the newest started April 21, 2025. A recall usually concerns specific lots, not every product.
What Prolia is
Each Prolia product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Denosumab · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| denosumab 60 mg/mL injection (subcutaneous) | Prolia | 7 products, 6 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Denosumab →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125320 | Amgen | June 1, 2010 | 1 |
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 60 mg/mL injection | Brand: Prolia | $1,863.22 per mL |
NADAC list of November 4, 2026; these prices took effect on 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 Prolia
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Prolia products.
- Amgen, Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.