FDA.reportPublic FDA data

JYNNEOS

Product NDC
50632-001
11-digit product format
506320001
Labeler code
50632
Product ID
50632-001_852e6c10-2932-4263-a658-8011aec61dfc
Type
VACCINE
Nonproprietary name
Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Bavarian Nordic A/S
Application
BLA125678
Marketing category
BLA
Marketing start
2021-03-17
Substance
VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN
Active strength
50000000 1/.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JYNNEOS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN50000000 1/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50632-001-01JYNNEOS0.5 mL in 1 VIALINJECTION, SUSPENSION0.511
50632-001-02JYNNEOS20 in 1 CARTONINJECTION, SUSPENSION2011
50632-001-03JYNNEOS10 in 1 CARTONINJECTION, SUSPENSION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50632-001-01ML - Milliliter50632-001f3e05491-acc2-4cba-be2d-618e1309bbab12022-03-09
50632-001-02ML - Milliliter50632-001e97145f5-fab1-4159-95d7-f7a036e8f1f012022-03-09
50632-001-03ML - Milliliter50632-00135df72b3-5ec1-4d67-978f-a3101e7a2cee12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50632-001JYNNEOS (VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN) INJECTION, SUSPENSION [BAVARIAN NORDIC A/S]11Current NDC, Legacy NDC, 3 package rows20231122_69fc3841-a461-4706-bdcb-1176c40bf486.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2464832JYNNEOS smallpox and monkeypox vaccine, live 0.5 mL InjectionPSN69fc3841-a461-4706-bdcb-1176c40bf48611
2464827smallpox and monkeypox vaccine, live 0.5 mL InjectionPSN69fc3841-a461-4706-bdcb-1176c40bf48611
24648320.5 ML modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML Injection [Jynneos]SBD69fc3841-a461-4706-bdcb-1176c40bf48611
24648270.5 ML modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML InjectionSCD69fc3841-a461-4706-bdcb-1176c40bf48611
2464832JYNNEOS smallpox and monkeypox vaccine, live 0.5 ML InjectionSY69fc3841-a461-4706-bdcb-1176c40bf48611
2464827modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML per 0.5 MLInjectionSY69fc3841-a461-4706-bdcb-1176c40bf48611
2464827modified Vaccinia Ankara-Bavarian Nordic 395000000 UNT per 1 ML InjectionSY69fc3841-a461-4706-bdcb-1176c40bf48611
2464827MVA-BN 198000000 UNT/ML per 0.5 MLInjectionSY69fc3841-a461-4706-bdcb-1176c40bf48611
2464827smallpox and monkeypox vaccine, live 0.5 mL InjectionSY69fc3841-a461-4706-bdcb-1176c40bf48611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50632-001-01506320001010.5 mL in 1 VIAL0.5 mlHistorical
50632-001-025063200010220 VIAL in 1 CARTON (50632-001-02) / .5 mL in 1 VIAL (50632-001-01) 20 vial2021-03-170000-00-00NoNoCurrent
50632-001-035063200010310 VIAL in 1 CARTON (50632-001-03) / .5 mL in 1 VIAL (50632-001-01) 10 vial2021-03-17NoNoHistorical