FDA.reportPublic FDA data

Ixiaro

Product NDC
62195-051
11-digit product format
621950051
Labeler code
62195
Product ID
62195-051_4465dc2b-20b5-35ba-e063-6394a90a468a
Type
VACCINE
Nonproprietary name
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Vetter Pharma Fertigung GmbH & Co. KG
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 ug/.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 ug/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62195-051-01Ixiaro0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62195-051IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED) INJECTION, SUSPENSION [VETTER PHARMA FERTIGUNG GMBH & CO. KG]9Current NDC, Legacy NDC, 1 package rows20241024_276b84fb-096b-3f91-e054-00144ff8d46c.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 SyringePSN276b84fb-096b-3f91-e054-00144ff8d46c10
1300781Japanese encephalitis vaccine 6 MCG in 0.5 ML Prefilled SyringePSN276b84fb-096b-3f91-e054-00144ff8d46c10
13007830.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe [Ixiaro]SBD276b84fb-096b-3f91-e054-00144ff8d46c10
13007810.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled SyringeSCD276b84fb-096b-3f91-e054-00144ff8d46c10
13007830.5 ML Ixiaro 0.012 MG/ML Prefilled SyringeSY276b84fb-096b-3f91-e054-00144ff8d46c10
1300783Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) 0.012 MG/ML 0.5 ML Prefilled SyringeSY276b84fb-096b-3f91-e054-00144ff8d46c10
1300783Ixiaro 6 MCG per 0.5 ML Prefilled SyringeSY276b84fb-096b-3f91-e054-00144ff8d46c10
1300781Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 6 MCG per 0.5 ML Prefilled SyringeSY276b84fb-096b-3f91-e054-00144ff8d46c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62195-051-0162195005101.5 mL in 1 SYRINGE (62195-051-01) 2009-03-300000-00-00NoNoCurrent