FDA.reportPublic FDA data

IXIARO

Product NDC
42515-002
11-digit product format
425150002
Labeler code
42515
Product ID
42515-002_f3d13c93-5fce-43db-b25f-8e1c8cd1dfb8
Type
VACCINE
Nonproprietary name
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Valneva Scotland Ltd.
Application
BLA125280
Marketing category
BLA
Marketing start
2009-03-30
Substance
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
6 [arb'U]/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Inactivated Japanese Encephalitis Virus Vaccine [EPC], Japanese Encephalitis Vaccines [CS], Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IXIARO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)6 [arb'U]/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42515-002-01IXIARO0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42515-002-01ML - Milliliter42515-002f4a20679-eef4-4324-8164-abde7cd1bd1f12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42515-002IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED) INJECTION, SUSPENSION [VALNEVA SCOTLAND LTD.]3Current NDC, Legacy NDC, 1 package rows20221208_e654303b-b7b1-4e5b-a0a1-e999110060bf.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125280IxiaroJapanese Encephalitis Vaccine, Inactivated, Adsorbed351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300783IXIARO 6 MCG in 0.5 ML Prefilled SyringePSNe654303b-b7b1-4e5b-a0a1-e999110060bf3
1300781Japanese encephalitis vaccine 6 MCG in 0.5 ML Prefilled SyringePSNe654303b-b7b1-4e5b-a0a1-e999110060bf3
13007830.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe [Ixiaro]SBDe654303b-b7b1-4e5b-a0a1-e999110060bf3
13007810.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled SyringeSCDe654303b-b7b1-4e5b-a0a1-e999110060bf3
13007830.5 ML Ixiaro 0.012 MG/ML Prefilled SyringeSYe654303b-b7b1-4e5b-a0a1-e999110060bf3
1300783Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) 0.012 MG/ML 0.5 ML Prefilled SyringeSYe654303b-b7b1-4e5b-a0a1-e999110060bf3
1300783Ixiaro 6 MCG per 0.5 ML Prefilled SyringeSYe654303b-b7b1-4e5b-a0a1-e999110060bf3
1300781Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 6 MCG per 0.5 ML Prefilled SyringeSYe654303b-b7b1-4e5b-a0a1-e999110060bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42515-002-0142515000201.5 mL in 1 SYRINGE (42515-002-01) 2009-03-300000-00-00NoNoCurrent