Vaccine · BLA
Ixiaro NDC 42515-002
japanese encephalitis vaccine, inactivated, adsorbed · Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 [arb'U]/.5mL · Injection, Suspension · Intramuscular · Valneva Scotland Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42515-002-01 | 4251500020142515000201 | .5 mL in 1 SYRINGE (42515-002-01)Marketed from Mar 30, 2009 |
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)
- Ixiaro
- Generic name (nonproprietary)
- japanese encephalitis vaccine, inactivated, adsorbed
- Active ingredients
- Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) — 6 [arb'U]/.5mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- Valneva Scotland Ltd.NDC labeler code 42515
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125280
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)Japanese Encephalitis Vaccines (Chemical structure)Inactivated (Chemical structure)
- Identifiers
- Product ID 42515-002_f3d13c93-5fce-43db-b25f-8e1c8cd1dfb8SPL ID f3d13c93-5fce-43db-b25f-8e1c8cd1dfb8
- Pharmacologic class
- Inactivated Japanese Encephalitis Virus Vaccine
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
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N442515000201followed by a unit qualifier and the quantityPackage 42515-0002-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 42515-002
- What is NDC 42515-002?
- 42515-002 is the product NDC for Ixiaro, Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 [arb'U]/.5mL injection, suspension, listed with the FDA by Valneva Scotland Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed).
- What is the active ingredient?
- Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated).
- Who is the labeler?
- Valneva Scotland Ltd., NDC labeler code 42515. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ixiaro?
- 1 other product NDC are listed under this name. See all Ixiaro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ixiaro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ixiarojapanese encephalitis vaccine, inactivated, adsorbed | Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 ug/.5mL | Injection, SuspensionIntramuscular | Vetter Pharma Fertigung GmbH & Co. KG | 62195-051 | 62195-0051-01 |
Other NDCs under BLA 125280
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ixiarojapanese encephalitis vaccine, inactivated, adsorbed | Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 ug/.5mL | Injection, SuspensionIntramuscular | Vetter Pharma Fertigung GmbH & Co. KG | 62195-051 |