What is NDC 78206-193?

78206-193 is the product NDC for Bildyos (denosumab), Denosumab 60 mg/mL injection, solution, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bildyos?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Yes: J0897, Injection, denosumab, 1 mg.

Bildyos NDC 78206-193 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-193Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0193Add 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
78206-193-01	7820601930178206019301	1 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASSMarketed from Sep 11, 2025

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): Bildyos
Generic name (nonproprietary): denosumab
Active ingredients: Denosumab — 60 mg/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Organon LLCNDC labeler code 78206
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761444
Marketing start: Sep 11, 2025
Listing expires: Dec 31, 2027
Other FDA classes: RANK Ligand Blocking Activity (Mechanism)
Identifiers: Product ID 78206-193_5958fefc-c45c-0cde-e063-6294a90a0887SPL ID 5958fefc-c45c-0cde-e063-6294a90a0887SPL set ID b9e32bf7-d70a-4083-8577-c15751c7f769RxCUI 2723350, 2723357UNII 4EQZ6YO2HIUPC 0378206193018
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

N478206019301 followed by a unit qualifier and the quantity

Package 78206-0193-01. 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 Aug 18, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: 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 Bildyos is indicated for the tre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 78206-193

What is NDC 78206-193?: 78206-193 is the product NDC for Bildyos (denosumab), Denosumab 60 mg/mL injection, solution, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bildyos (Denosumab).
What is the active ingredient?: Denosumab.
Who is the labeler?: Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bildyos?: 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 761444

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

FDA NDC Directory listings under BLA 761444
Product	Strength	Form · route	Labeler	Product NDC
Bilprevdadenosumab	Denosumab 120 mg/1.7mL	Injection, SolutionSubcutaneous	Organon LLC	78206-195

Bildyos (Denosumab) NDC 78206-193