What is NDC 65219-668?

65219-668 is the product NDC for Conexxence (denosumab), Denosumab 60 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Conexxence?

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

Is there a related HCPCS / J-code?

Yes: J0897, Injection, denosumab, 1 mg.

Conexxence NDC 65219-668 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-668Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0668Add 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
65219-668-01	65219066801	1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTICMarketed from Jun 30, 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): Conexxence
Generic name (nonproprietary): denosumab
Active ingredients: Denosumab — 60 mg/mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761398
Marketing start: Jun 30, 2025
Listing expires: Dec 31, 2026
Other FDA classes: RANK Ligand Blocking Activity (Mechanism)
Identifiers: Product ID 65219-668_f778a079-d075-4205-bc94-8ec67e27c95eSPL ID f778a079-d075-4205-bc94-8ec67e27c95eSPL set ID 39a0a789-778f-4695-b3a9-61643e6396cdRxCUI 2717531, 2717538UNII 4EQZ6YO2HIUPC 0365219668015
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

N465219066801 followed by a unit qualifier and the quantity

Package 65219-0668-01. 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 Dec 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Conexxence 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 Conexxence is indicated for the tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-668

What is NDC 65219-668?: 65219-668 is the product NDC for Conexxence (denosumab), Denosumab 60 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Conexxence (Denosumab).
What is the active ingredient?: Denosumab.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Conexxence?: 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 761398

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

FDA NDC Directory listings under BLA 761398
Product	Strength	Form · route	Labeler	Product NDC
Bomyntradenosumab	Denosumab 70 mg/mL	InjectionSubcutaneous	Fresenius Kabi USA, LLC	65219-670
Bomyntradenosumab	Denosumab 70 mg/mL	InjectionSubcutaneous	Fresenius Kabi USA, LLC	65219-672

Conexxence (Denosumab) NDC 65219-668