FDA.reportPublic FDA data

VIMKUNYA

Product NDC
50632-018
11-digit product format
506320018
Labeler code
50632
Product ID
50632-018_cff3eb6b-993d-4dff-a6d8-64b03d33ee56
Type
VACCINE
Nonproprietary name
Chikungunya Vaccine, Recombinant
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Bavarian Nordic A/S
Application
BLA125820
Marketing category
BLA
Marketing start
2025-03-01
Substance
CHIKUNGUNYA VIRUS SENEGAL STRAIN 37997 CAPSID PROTEIN; CHIKUNGUNYA VIRUS SENEGAL STRAIN 37997 ENVELOPE PROTEIN E1; CHIKUNGUNYA VIRUS SENEGAL STRAIN 37997 ENVELOPE PROTEIN E2
Active strength
10; 15; 15 ug/.8mL; ug/.8mL; ug/.8mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHIKUNGUNYA VIRUS SENEGAL STRAIN 37997 CAPSID PROTEIN10 ug/.8mL
CHIKUNGUNYA VIRUS SENEGAL STRAIN 37997 ENVELOPE PROTEIN E115 ug/.8mL
CHIKUNGUNYA VIRUS SENEGAL STRAIN 37997 ENVELOPE PROTEIN E215 ug/.8mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50632-018-02VIMKUNYA1 in 1 CARTONINJECTION, SUSPENSION12
50632-018-04VIMKUNYA0.8 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION0.82

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50632-018-02ML - Milliliter50632-0187ecb40ee-73ae-4004-85b0-c6b5cb9aed5612025-03-04
50632-018-04ML - Milliliter50632-0180757fb79-da3a-4d2c-9097-69aceb8ba8e512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50632-018VIMKUNYA (CHIKUNGUNYA VACCINE, RECOMBINANT) INJECTION, SUSPENSION [BAVARIAN NORDIC A/S]1Current NDC, 2 package rows20250302_5e9a8ff0-3fdf-448a-97b3-83e6b904d864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2707126chikungunya virus antigen, recombinant Senegal strain 37997 vaccine, recombinant 0.8 ML Prefilled SyringePSN5e9a8ff0-3fdf-448a-97b3-83e6b904d8642
2707132Vimkunya vaccine, recombinant 0.8 ML Prefilled SyringePSN5e9a8ff0-3fdf-448a-97b3-83e6b904d8642
27071320.8 ML chikungunya virus antigen, recombinant Senegal strain 37997 0.05 MG/ML Prefilled Syringe [Vimkunya]SBD5e9a8ff0-3fdf-448a-97b3-83e6b904d8642
27071260.8 ML chikungunya virus antigen, recombinant Senegal strain 37997 0.05 MG/ML Prefilled SyringeSCD5e9a8ff0-3fdf-448a-97b3-83e6b904d8642
2707126chikungunya virus antigen, recombinant Senegal strain 37997 vaccine, recombinant 0.8 ML Prefilled SyringeSY5e9a8ff0-3fdf-448a-97b3-83e6b904d8642
2707132Vimkunya vaccine, recombinant 0.8 ML Prefilled SyringeSY5e9a8ff0-3fdf-448a-97b3-83e6b904d8642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50632-018-02506320018021 SYRINGE, GLASS in 1 CARTON (50632-018-02) / .8 mL in 1 SYRINGE, GLASS (50632-018-04) 2025-03-01NoNoHistorical
50632-018-04506320018040.8 mL in 1 SYRINGE, GLASS0.8 mlHistorical