FDA.reportPublic FDA data

IMOVAX RABIES

Product NDC
49281-252
11-digit product format
492810252
Labeler code
49281
Product ID
49281-252_d3a946ba-6644-4574-9c5f-90f9b06e3867
Type
VACCINE
Nonproprietary name
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) and WATER
Dosage form
KIT
Labeler
Sanofi Vaccines US Inc.
Application
BLA103931
Marketing category
BLA
Marketing start
2019-10-25
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IMOVAX RABIES
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49281-252-512025-08-13C16284748780-13b156c62-2c0f-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use IMOVAX® RABIES safely and effectively. See full prescribing information for IMOVAX® RABIES. IMOVAX® RABIES (Rabies Vaccine) for injectable suspension, for intramuscular use Initial U.S. Approval: 1980
49281-252-512025-07-29C16284748780-13b156c62-2c0f-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use IMOVAX® RABIES safely and effectively. See full prescribing information for IMOVAX® RABIES. IMOVAX® RABIES (Rabies Vaccine) for injectable suspension, for intramuscular use Initial U.S. Approval: 1980

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-246-58IMOVAX RABIES1 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1 mL2.5 [iU] in 1mL24
49281-252-51IMOVAX RABIES1 in 1 PACKAGEKIT124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-252-51EA - Each49281-2521fba0443-69ae-4d8b-a78e-edbd902e83ef12020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED)ACTIVE INGREDIENTC4HQF74XMWIMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED)ACTIVE MOIETYC4HQF74XMWIMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6
ALBUMIN (HUMAN)INACTIVE INGREDIENTZIF514RVZRIMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6
NEOMYCIN SULFATEINACTIVE INGREDIENT057Y626693IMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-252IMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]20Current NDC, Legacy NDC, 2 package rows20240801_ba8d4e72-f452-4859-ae6f-3644b4b0a78c.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103931Imovax RabiesRabies Vaccine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830470IMOVAX rabies vaccine 2.5 UNT in 1 ML InjectionPSNba8d4e72-f452-4859-ae6f-3644b4b0a78c24
830467rabies virus vaccine (generic for Imovax) 2.5 UNT in 1 ML InjectionPSNba8d4e72-f452-4859-ae6f-3644b4b0a78c24
8304701 ML rabies virus vaccine wistar strain PM-1503-3M (human), inactivated 2.5 UNT/ML Injection [Imovax]SBDba8d4e72-f452-4859-ae6f-3644b4b0a78c24
8304671 ML rabies virus vaccine wistar strain PM-1503-3M (human), inactivated 2.5 UNT/ML InjectionSCDba8d4e72-f452-4859-ae6f-3644b4b0a78c24
8304701 ML Imovax 2.5 UNT/ML InjectionSYba8d4e72-f452-4859-ae6f-3644b4b0a78c24
830470Imovax Rabies, Wistar Rabies Virus Strain PM-1503-3M (Human) 2.5 UNT per 1 ML InjectionSYba8d4e72-f452-4859-ae6f-3644b4b0a78c24
830467rabies virus vaccine wistar strain PM-1503-3M (human), inactivated 2.5 UNT per 1 ML InjectionSYba8d4e72-f452-4859-ae6f-3644b4b0a78c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-246-58492810246581 mL in 1 VIAL, SINGLE-USE1 mlHistorical
49281-252-51492810252511 KIT in 1 PACKAGE (49281-252-51) * 1 mL in 1 VIAL, SINGLE-USE (49281-246-58) * 1 mL in 1 SYRINGE (49281-263-58) 1 kit2019-10-250000-00-00NoNoCurrent