Osvyrti (denosumab-desu) NDC 69448-021 · J-Code J0897

NDC codes

FDA NDC Directory

Product NDC (as listed)69448-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69448-0021Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69448-021-63	69448002163	1 SYRINGE in 1 CARTON (69448-021-63) / 1 mL in 1 SYRINGEMarketed from Jul 6, 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): Osvyrti
Generic name (nonproprietary): denosumab-desu
Active ingredients: Denosumab — 60 mg/mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Accord BioPharma Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761424
Marketing start: Jul 6, 2026
Listing expires: Dec 31, 2027
Other FDA classes: RANK Ligand Blocking Activity (Mechanism)
Identifiers: Product ID 69448-021_b22cd858-906b-4d8c-9925-24a5b7e16665SPL ID b22cd858-906b-4d8c-9925-24a5b7e16665SPL set ID 5f3be096-5100-4d0e-b765-481bbb2672e1RxCUI 2746871, 2746878UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N469448002163 followed by a unit qualifier and the quantity

Package 69448-0021-63. 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 Jul 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

OSVYRTI is a RANK ligand (RANKL) inhibitor indicated for: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture OSVYRTI is indicated for the treatment of postm…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761424

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761424
Product	Strength	Form · route	Labeler	Product NDC
Jubereqdenosumab-desu	Denosumab 70 mg/mL	InjectionSubcutaneous	Accord BioPharma Inc.	69448-022