FDA.reportPublic FDA data

Diluent Component

Product NDC
50632-003
11-digit product format
506320003
Labeler code
50632
Product ID
50632-003_b8f81332-4a93-4b01-89b9-3952565ab2e9
Type
VACCINE
Nonproprietary name
Water for Injection
Dosage form
LIQUID
Route
SUBCUTANEOUS
Labeler
Bavarian Nordic A/S
Application
BLA125678
Marketing category
BLA
Marketing start
2025-04-14
Substance
WATER
Active strength
.65 mL/.65mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER.65 mL/.65mL

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
50632-003-01Diluent Component0.65 mL in 1 VIALLIQUID0.653
50632-003-02Diluent Component20 in 1 CARTONLIQUID203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50632-003JYNNEOS (VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN) INJECTION, SUSPENSION JYNNEOS (VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION DILUENT COMPONENT (WATER FOR INJECTION) LIQUID [BAVARIAN NORDIC A/S]3Current NDC, 2 package rows20250416_d3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2464832JYNNEOS smallpox and monkeypox vaccine, live 0.5 mL InjectionPSNd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
2464827smallpox and monkeypox vaccine, live 0.5 mL InjectionPSNd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
24648320.5 ML modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML Injection [Jynneos]SBDd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
24648270.5 ML modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML InjectionSCDd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
2464832JYNNEOS smallpox and monkeypox vaccine, live 0.5 ML InjectionSYd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
2464827modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML per 0.5 MLInjectionSYd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
2464827modified Vaccinia Ankara-Bavarian Nordic 395000000 UNT per 1 ML InjectionSYd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
2464827MVA-BN 198000000 UNT/ML per 0.5 MLInjectionSYd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3
2464827smallpox and monkeypox vaccine, live 0.5 mL InjectionSYd3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50632-003-01506320003010.65 mL in 1 VIAL0.65 mlHistorical
50632-003-025063200030220 VIAL in 1 CARTON (50632-003-02) / .65 mL in 1 VIAL (50632-003-01) 20 vial2025-04-14NoNoCurrent