JYNNEOS
- Product NDC
- 50632-002
- 11-digit product format
- 506320002
- Labeler code
- 50632
- Product ID
- 50632-002_b8f81332-4a93-4b01-89b9-3952565ab2e9
- Type
- VACCINE
- Nonproprietary name
- Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- SUBCUTANEOUS
- Labeler
- Bavarian Nordic A/S
- Application
- BLA125678
- Marketing category
- BLA
- Marketing start
- 2025-04-14
- 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| Ingredient | Strength |
|---|
| VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN | 50000000 1/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50632-002-01 | JYNNEOS | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 0.5 | | 3 |
| 50632-002-02 | JYNNEOS | 20 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50632-002 | JYNNEOS (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] | 3 | Current NDC, 2 package rows | 20250416_d3a52eba-83d2-4fd1-8db5-dd04bcb1ba9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50632-002-01 | 50632000201 | 0.5 mL in 1 VIAL | 0.5 ml | | | | Historical |
| 50632-002-02 | 50632000202 | 20 VIAL in 1 CARTON (50632-002-02) / .5 mL in 1 VIAL (50632-002-01) | 20 vial | 2025-04-14 | No | No | Historical |