FDA.reportPublic FDA data

Dengvaxia

Product NDC
49281-605
11-digit product format
492810605
Labeler code
49281
Product ID
49281-605_5bb45ef6-847d-431f-83b6-6b8e5ac5f121
Type
VACCINE
Nonproprietary name
Dengue Tetravalent Vaccine, Live
Dosage form
KIT
Labeler
Sanofi Vaccines US Inc.
Application
BLA125682
Marketing category
BLA
Marketing start
2019-05-01
Marketing end
2026-08-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dengvaxia

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49281-605-012025-08-14C16284748780-13b156c62-29a0-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use DENGVAXIA safely and effectively. See full prescribing information for DENGVAXIA. DENGVAXIA (Dengue Tetravalent Vaccine, Live) Suspension for Subcutaneous Injection Initial U.S. Approval: 2019
49281-605-012025-07-29C16284748780-13b156c62-29a0-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use DENGVAXIA safely and effectively. See full prescribing information for DENGVAXIA. DENGVAXIA (Dengue Tetravalent Vaccine, Live) Suspension for Subcutaneous Injection Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-605-01Dengvaxia1 in 1 CARTONKIT110
49281-606-58Dengvaxia0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,0.5 mL100000 [CCID_50] in 0.5mL10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-605-01EA - Each49281-605ec84fdbd-6acd-43f6-9dfe-1d77ae9edb9a12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-605DENGVAXIA (DENGUE TETRAVALENT VACCINE, LIVE) KIT [SANOFI PASTEUR INC.]8Current NDC, Legacy NDC, 2 package rows20231019_280ee057-3488-4d77-b510-8bc733eeca1e.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125682DengvaxiaDengue Tetravalent Vaccine, Live351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2197701dengue tetravalent vaccine live 0.5 mL InjectionPSN280ee057-3488-4d77-b510-8bc733eeca1e10
2197703dengvaxia tetravalent vaccine live 0.5 ML InjectionPSN280ee057-3488-4d77-b510-8bc733eeca1e10
2197703dengue virus live antigen, CYD serotype 1 100000 UNT / dengue virus live antigen, CYD serotype 2 100000 UNT / dengue virus live antigen, CYD serotype 3 100000 UNT / dengue virus live antigen, CYD serotype 4 100000 UNT Injection [Dengvaxia]SBD280ee057-3488-4d77-b510-8bc733eeca1e10
2197701dengue virus live antigen, CYD serotype 1 100000 UNT / dengue virus live antigen, CYD serotype 2 100000 UNT / dengue virus live antigen, CYD serotype 3 100000 UNT / dengue virus live antigen, CYD serotype 4 100000 UNT InjectionSCD280ee057-3488-4d77-b510-8bc733eeca1e10
2197701dengue tetravalent vaccine live 0.5 ML InjectionSY280ee057-3488-4d77-b510-8bc733eeca1e10
2197703Dengvaxia tetravalent vaccine live 0.5 ML InjectionSY280ee057-3488-4d77-b510-8bc733eeca1e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-605-01492810605011 KIT in 1 CARTON (49281-605-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-606-58) * .6 mL in 1 VIAL, SINGLE-DOSE (49281-549-58) 1 kit2019-05-012026-08-31NoNoCurrent
49281-606-58492810606580.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical