NDC codes

FDA NDC Directory
Product NDC (as listed)62195-051Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62195-0051Add 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
62195-051-016219500510162195005101.5 mL in 1 SYRINGE (62195-051-01)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
Dosage form
Injection, Suspension
Route
Intramuscular
Labeler
Vetter Pharma Fertigung GmbH & Co. KGNDC labeler code 62195
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 62195-051_4465dc2b-20b5-35ba-e063-6394a90a468aSPL ID 4465dc2b-20b5-35ba-e063-6394a90a468a
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

N462195005101 followed by a unit qualifier and the quantity

Package 62195-0051-01. 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 62195-051

What is NDC 62195-051?
62195-051 is the product NDC for Ixiaro, Japanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 ug/.5mL injection, suspension, listed with the FDA by Vetter Pharma Fertigung GmbH & Co. KG. 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?
Vetter Pharma Fertigung GmbH & Co. KG, NDC labeler code 62195. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ixiaro NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ixiarojapanese encephalitis vaccine, inactivated, adsorbedJapanese encephalitis virus strain SA 14-14-2 antigen (Formaldehyde inactivated) 6 [arb'U]/.5mLInjection, SuspensionIntramuscularValneva Scotland Ltd.42515-00242515-0002-01

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 [arb'U]/.5mLInjection, SuspensionIntramuscularValneva Scotland Ltd.42515-002

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