Tyenne (tocilizumab-aazg) NDC 65219-594

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-594Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0594Add 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
65219-594-20	65219059420	1 VIAL, SINGLE-DOSE in 1 CARTON (65219-594-20) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 15, 2024

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): Tyenne
Generic name (nonproprietary): tocilizumab-aazg
Active ingredients: Tocilizumab — 400 mg/20mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761275
Marketing start: Apr 15, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Interleukin 6 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65219-594_363d125e-6d69-4bb2-ae09-5eeb5d9edbaeSPL ID 363d125e-6d69-4bb2-ae09-5eeb5d9edbaeSPL set ID e400bbe6-43c5-4de6-82b9-cb44ce3cd906RxCUI 2679431, 2679438, 2679440, 2679441, 2679442, 2679443UNII I031V2H011
Pharmacologic class: Interleukin-6 Receptor Antagonist

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 codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

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

N465219059420 followed by a unit qualifier and the quantity

Package 65219-0594-20. 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 May 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

TYENNE ® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) • Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) • Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761275

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

FDA NDC Directory listings under BLA 761275
Product	Strength	Form · route	Labeler	Product NDC
Tyennetocilizumab-aazg	Tocilizumab 162 mg/.9mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	65219-584
Tyennetocilizumab-aazg	Tocilizumab 162 mg/.9mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	65219-586
Tyennetocilizumab-aazg	Tocilizumab 80 mg/4mL	Injection, Solution, ConcentrateIntravenous	Fresenius Kabi USA, LLC	65219-590
Tyennetocilizumab-aazg	Tocilizumab 200 mg/10mL	Injection, Solution, ConcentrateIntravenous	Fresenius Kabi USA, LLC	65219-592