IXIARO

Product NDC: 42515-001
11-digit product format: 425150001
Labeler code: 42515
Product ID: 42515-001_2b9ca64f-f730-4365-8e73-ff2ce802be4f
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
Marketing end: 0000-00-00
Substance: JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength: 6 ug/.5mL
Pharmacologic classes: Inactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [CS],Vaccines, Inactivated [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42515-001		I	Inactivated by FDA		2026-07-31
excluded package	package	42515-001	42515-001-01	I	Inactivated by FDA		2026-07-31

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42515-001-01	2020-01-31	C162847	48780-1	9d75b9d0-2d7f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use IXIARO safely and effectively. See full prescribing information for IXIARO. IXIARO (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Suspension for Intramuscular Injection Initial U.S. Approval: 2009

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42515-001-01	IXIARO	0.5 mL in 1 SYRINGE	INJECTION, SUSPENSION	0.5		4

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42515-001-01	ML - Milliliter	42515-001	60965517-194d-43fa-870c-1ffb7f1799e3	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	DZ854I04ZE	IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED) INJECTION, SUSPENSION [VALNEVA SCOTLAND LTD.]	4
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	DZ854I04ZE	IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED) INJECTION, SUSPENSION [VALNEVA SCOTLAND LTD.]	4
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED) INJECTION, SUSPENSION [VALNEVA SCOTLAND LTD.]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42515-001	IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED) INJECTION, SUSPENSION [VALNEVA SCOTLAND LTD.]	4	Legacy NDC, 1 package rows	20150303_b68b7911-628d-4932-b0e8-4ae72c48f92f.zip

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125280	Ixiaro	Japanese Encephalitis Vaccine, Inactivated, Adsorbed	351(a)	Rx	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
DZ854I04ZE	JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)	JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1300783	IXIARO 6 MCG in 0.5 ML Prefilled Syringe	PSN	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300781	Japanese encephalitis vaccine 6 MCG in 0.5 ML Prefilled Syringe	PSN	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300783	0.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe [Ixiaro]	SBD	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300781	0.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe	SCD	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300783	0.5 ML Ixiaro 0.012 MG/ML Prefilled Syringe	SY	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300783	Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) 0.012 MG/ML 0.5 ML Prefilled Syringe	SY	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300783	Ixiaro 6 MCG per 0.5 ML Prefilled Syringe	SY	b68b7911-628d-4932-b0e8-4ae72c48f92f	4
1300781	Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 6 MCG per 0.5 ML Prefilled Syringe	SY	b68b7911-628d-4932-b0e8-4ae72c48f92f	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42515-001-01	42515000101	0.5 mL in 1 SYRINGE	0.5 ml	Historical