Prescription drug · BLA
Jubereq (Denosumab-desu) NDC 69448-022
Denosumab 70 mg/mL · Injection · Subcutaneous · Accord BioPharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69448-022-63 | 6944800226369448002263 | 1 VIAL, SINGLE-USE in 1 CARTON (69448-022-63) / 1.7 mL in 1 VIAL, SINGLE-USEMarketed from Jul 13, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Jubereq
- Generic name (nonproprietary)
- denosumab-desu
- Active ingredients
- Denosumab — 70 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Accord BioPharma Inc.NDC labeler code 69448
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761424
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 69448-022_caa201eb-143f-4390-9788-894e1810fee8SPL ID caa201eb-143f-4390-9788-894e1810fee8SPL set ID e15dfe74-1575-4a2a-895e-323c05613362RxCUI 2747255, 2747262UNII 4EQZ6YO2HI
- Pharmacologic class
- RANK Ligand Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J0897 — Injection, denosumab, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
Denosumab biosimilars have their own HCPCS codes.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N469448002263followed by a unit qualifier and the quantityPackage 69448-0022-63. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Jubereq is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Jubereq is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell…
Excerpt only. Read the full label for complete information.
About NDC 69448-022
- What is NDC 69448-022?
- 69448-022 is the product NDC for Jubereq (denosumab-desu), Denosumab 70 mg/mL injection, listed with the FDA by Accord BioPharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jubereq (Denosumab-desu).
- What is the active ingredient?
- Denosumab.
- Who is the labeler?
- Accord BioPharma Inc., NDC labeler code 69448. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jubereq?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Yes: J0897, Injection, denosumab, 1 mg. See Billing references above.
Other NDCs under BLA 761424
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Osvyrtidenosumab-desu | Denosumab 60 mg/mL | InjectionSubcutaneous | Accord BioPharma Inc. | 69448-021 |