Prescription drug · BLA
Tysabri (Natalizumab) NDC 64406-008
Natalizumab 300 mg/15mL · Injection · Intravenous · Biogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-008-01 | 6440600080164406000801 | 1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) / 15 mL in 1 VIAL, SINGLE-USEMarketed from Nov 23, 2004 |
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)
- Tysabri
- Generic name (nonproprietary)
- natalizumab
- Active ingredients
- Natalizumab — 300 mg/15mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Biogen Inc.NDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125104
- Marketing start
- Listing expires
- Other FDA classes
- Integrin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 64406-008_119c87a9-d153-4796-9525-694afdcdc1d6SPL ID 119c87a9-d153-4796-9525-694afdcdc1d6SPL set ID c5fdde91-1989-4dd2-9129-4f3323ea2962RxCUI 477484, 603541UNII 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
N464406000801followed by a unit qualifier and the quantityPackage 64406-0008-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYSABRI 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. TYSABRI increases the risk of PML [See Warnings and Precautions ( 5.1 ) ]. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. ( 1.1 ) Crohn's Disease (CD) TYSABRI is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severe…
Excerpt only. Read the full label for complete information.
About NDC 64406-008
- What is NDC 64406-008?
- 64406-008 is the product NDC for Tysabri (natalizumab), Natalizumab 300 mg/15mL injection, listed with the FDA by Biogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tysabri (Natalizumab).
- What is the active ingredient?
- Natalizumab.
- Who is the labeler?
- Biogen Inc., NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tysabri?
- 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.