NDC codes

FDA NDC Directory
Product NDC (as listed)42515-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42515-0002Add 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 NDC11-digit (billing)PackageCopy
42515-002-0142515000201.5 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
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.

How CPT relates to drug billing

NDC on a medical claim

N442515000201 followed by a unit qualifier and the quantity

Package 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.

Other NDCs under BLA 125280

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

FDA NDC Directory listings under BLA 125280
ProductStrengthForm · routeLabelerProduct NDC
Ixiarojapanese encephalitis vaccine, inactivated, adsorbedJapanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 ug/.5mLInjection, SuspensionIntramuscularVetter Pharma Fertigung GmbH & Co. KG62195-051

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