NUVAXOVID COVID-19 Vaccine, Adjuvanted
- Product NDC
- 80631-207
- 11-digit product format
- 806310207
- Labeler code
- 80631
- Product ID
- 80631-207_ed93d31f-5a16-4907-b903-b859718c4dc7
- Type
- VACCINE
- Nonproprietary name
- nvx-cov2705
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Novavax, Inc.
- Application
- BLA125817
- Marketing category
- BLA
- Marketing start
- 2025-08-27
- Substance
- NVX-COV2705
- Active strength
- 5 ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NUVAXOVID COVID-19 Vaccine, Adjuvanted
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NVX-COV2705 | 5 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80631-207-01 | NUVAXOVID COVID-19 Vaccine, Adjuvanted | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SUSPENSION | 0.5 | 3 | |
| 80631-207-10 | NUVAXOVID COVID-19 Vaccine, Adjuvanted | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80631-207-01 | ML - Milliliter | 80631-207 | de62dd82-a76d-4783-af86-991d44071b4c | 1 | 2025-10-14 |
| 80631-207-10 | ML - Milliliter | 80631-207 | ae728ee5-97b8-4176-b8c3-47ed86c1ee89 | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2714928 | NUVAXOVID 2024-2025 vaccine 0.5 ML Prefilled Syringe | PSN | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2723014 | NUVAXOVID 2025-2026 vaccine 0.5 ML Prefilled Syringe | PSN | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2692309 | SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.5 ML Prefilled Syringe, 12y+ | PSN | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2714928 | 0.5 ML SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.01 MG/ML Prefilled Syringe [Nuvaxovid 2024-2025] | SBD | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2723014 | 0.5 ML SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.01 MG/ML Prefilled Syringe [Nuvaxovid 2025-2026] | SBD | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2692309 | 0.5 ML SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.01 MG/ML Prefilled Syringe | SCD | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2714928 | Nuvaxovid 2024-2025 vaccine 0.5 ML Prefilled Syringe | SY | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2723014 | Nuvaxovid 2025-2026 vaccine 0.5 ML Prefilled Syringe | SY | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
| 2692309 | SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.5 ML Prefilled Syringe, 12y+ | SY | 1a20513c-d255-46d7-8e6b-294cec4b44f4 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80631-207-01 | 80631020701 | 0.5 mL in 1 SYRINGE, GLASS | 0.5 ml | Historical | |||
| 80631-207-10 | 80631020710 | 10 SYRINGE, GLASS in 1 CARTON (80631-207-10) / .5 mL in 1 SYRINGE, GLASS (80631-207-01) | 2025-08-27 | No | No | Historical |