FDA.reportPublic FDA data

Spikevax

Product NDC
80777-114
11-digit product format
807770114
Labeler code
80777
Product ID
80777-114_7966274d-0378-44c8-9075-1df2c27aae9a
Type
VACCINE
Nonproprietary name
COVID-19 Vaccine, mRNA
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Application
BLA125752
Marketing category
BLA
Marketing start
2026-08-17
Substance
CX-055611
Active strength
50 ug/.5mL
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CX-05561150 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125752SpikevaxCOVID-19 Vaccine, mRNA351(a)Disc2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691172SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.25 ML Prefilled Syringe, 6m through 11yPSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2691175SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.5 ML Prefilled Syringe, 12y+PSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722428SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.25 ML Prefilled Syringe, 6m through 11yPSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722437SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+PSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2719760spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11yPSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2691181spikevax 2024-2025 vaccine, 0.5 ML Prefilled Syringe, 12y+PSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722435spikevax 2025-2026 vaccine, 0.25 ML Prefilled Syringe, 6m through 11yPSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722438spikevax 2025-2026 vaccine, 0.5 ML Prefilled Syringe, 12y+PSNf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27197600.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe [Spikevax 2024-2025]SBDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27224350.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe [Spikevax 2025-2026]SBDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
26911810.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe [Spikevax 2024-2025]SBDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27224380.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe [Spikevax 2025-2026]SBDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
26911720.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled SyringeSCDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27224280.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled SyringeSCDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
26911750.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled SyringeSCDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27224370.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled SyringeSCDf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27197600.25 ML Spikevax 2024-2025 0.1 MG/ML Prefilled SyringeSYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27224350.25 ML Spikevax 2025-2026 0.1 MG/ML Prefilled SyringeSYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
27224380.5 ML Spikevax 2025-2026 0.1 MG/ML Prefilled SyringeSYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2691172SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.25 ML Prefilled Syringe, 6m through 11ySYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2691175SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.5 ML Prefilled Syringe, 12y+SYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722428SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.25 ML Prefilled Syringe, 6m through 11ySYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722437SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+SYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2719760Spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11ySYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2691181Spikevax 2024-2025 vaccine, 0.5 ML Prefilled Syringe, 12y+SYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722435Spikevax 2025-2026 vaccine, 0.25 ML Prefilled Syringe, 6m through 11ySYf96b315c-fa57-4876-a7e5-a9b584d8e6e610
2722438Spikevax 2025-2026 vaccine, 0.5 ML Prefilled Syringe, 12y+SYf96b315c-fa57-4876-a7e5-a9b584d8e6e610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
80777-114-968077701149610 SYRINGE, PLASTIC in 1 CARTON (80777-114-96) / .5 mL in 1 SYRINGE, PLASTIC (80777-114-01)2026-08-170Current