Prescription drug · BLA
Tyruko (Natalizumab-sztn) NDC 61314-543
Natalizumab 300 mg/15mL · Injection · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-543-94 | 61314054394 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 17, 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)
- Tyruko
- Generic name (nonproprietary)
- natalizumab-sztn
- Active ingredients
- Natalizumab — 300 mg/15mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761322
- Marketing start
- Listing expires
- Other FDA classes
- Integrin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 61314-543_29c4086f-ca52-4f83-9119-bada7ec65482SPL ID 29c4086f-ca52-4f83-9119-bada7ec65482SPL set ID ef653c36-dd4b-4e71-9d2d-40b8fea24b67RxCUI 2725173, 2725180UNII 3JB47N2Q2P
- Pharmacologic class
- Integrin 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.
- NDC on a medical claim
N461314054394followed by a unit qualifier and the quantityPackage 61314-0543-94. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYRUKO is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Natalizumab products increase the risk of PML [see Warnings and Precautions ( 5.1 )] . When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk. ( 1.1 ) Crohn's Disease (CD) • TYRUKO is indicated for inducing and maintaining clinical response and remission in adult patients with moderately …
Excerpt only. Read the full label for complete information.
About NDC 61314-543
- What is NDC 61314-543?
- 61314-543 is the product NDC for Tyruko (natalizumab-sztn), Natalizumab 300 mg/15mL injection, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tyruko (Natalizumab-sztn).
- What is the active ingredient?
- Natalizumab.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tyruko?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.