Prescription drug · BLA
Itvisma (Onasemnogene abeparvovec-brve) NDC 71894-200
Onasemnogene abeparvovec 40000000000000 [arb'U]/mL · Injection, Suspension · Intrathecal · Novartis Innovative Technologies Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71894-200-02 | 71894020002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71894-200-02) / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01)Marketed from Nov 24, 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)
- Itvisma
- Generic name (nonproprietary)
- onasemnogene abeparvovec-brve
- Active ingredients
- Onasemnogene abeparvovec — 40000000000000 [arb'U]/mL
- Dosage form
- Injection, Suspension
- Route
- Intrathecal
- Labeler
- Novartis Innovative Technologies Inc.NDC labeler code 71894
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125856
- Marketing start
- Listing expires
- Identifiers
- Product ID 71894-200_68c25df1-ad2d-4bb0-8e19-e9a58b868d13SPL ID 68c25df1-ad2d-4bb0-8e19-e9a58b868d13SPL set ID ab2e1c6c-4f95-4243-9296-1734e0a30591RxCUI 2727307, 2727314UNII MLU3LU3EVV
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.
- NDC on a medical claim
N471894020002followed by a unit qualifier and the quantityPackage 71894-0200-02. 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)
ITVISMA is indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene. ITVISMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in SMN1 gene. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71894-200
- What is NDC 71894-200?
- 71894-200 is the product NDC for Itvisma (onasemnogene abeparvovec-brve), Onasemnogene abeparvovec 40000000000000 [arb'U]/mL injection, suspension, listed with the FDA by Novartis Innovative Technologies Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Itvisma (Onasemnogene abeparvovec-brve).
- What is the active ingredient?
- Onasemnogene abeparvovec.
- Who is the labeler?
- Novartis Innovative Technologies Inc., NDC labeler code 71894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Itvisma?
- 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.