FDA.reportPublic FDA data

Spikevax

Product NDC
80777-112
11-digit product format
807770112
Labeler code
80777
Product ID
80777-112_112d8af9-0172-4129-a89f-c76f20b366a7
Type
VACCINE
Nonproprietary name
COVID-19 Vaccine, mRNA
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Moderna US, Inc.
Application
BLA125752
Marketing category
BLA
Marketing start
2025-08-27
Substance
CX-051869
Active strength
50 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
Spikevax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CX-05186950 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80777-112-01Spikevax0.5 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION0.510
80777-112-88Spikevax2 in 1 CARTONINJECTION, SUSPENSION210
80777-112-93Spikevax10 in 1 CARTONINJECTION, SUSPENSION1010
80777-112-96Spikevax10 in 1 CARTONINJECTION, SUSPENSION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80777-112-01ML - Milliliter80777-112df2ce925-99aa-4606-a118-2faf9b75ac6a12025-09-12
80777-112-88ML - Milliliter80777-1124c2bfb43-9b9f-473f-8e99-9943686f3f9b12025-09-12
80777-112-96ML - Milliliter80777-112d6f4b399-1735-4f85-becf-c0ab9edfb47412025-09-12

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
80777-112-01807770112010.5 mL in 1 SYRINGE, PLASTIC0.5 mlHistorical
80777-112-88807770112882 SYRINGE, PLASTIC in 1 CARTON (80777-112-88) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01) 2025-08-27NoNoCurrent
80777-112-938077701129310 SYRINGE, PLASTIC in 1 CARTON (80777-112-93) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01) 2025-08-27NoNoCurrent
80777-112-968077701129610 SYRINGE, PLASTIC in 1 CARTON (80777-112-96) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01) 2025-08-27NoNoCurrent