FDA.reportPublic FDA data

mNEXSPIKE

Product NDC
80777-400
11-digit product format
807770400
Labeler code
80777
Product ID
80777-400_97c27eb6-1d2e-4953-afac-882ada70c6f8
Type
VACCINE
Nonproprietary name
COVID-19 Vaccine, mRNA
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Moderna US, Inc.
Application
BLA125835
Marketing category
BLA
Marketing start
2025-08-27
Substance
CX-052075
Active strength
10 ug/.2mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CX-05207510 ug/.2mL

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
80777-400-17mNEXSPIKE0.2 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION0.21
80777-400-60mNEXSPIKE10 in 1 CARTONINJECTION, SUSPENSION101
80777-400-61mNEXSPIKE2 in 1 CARTONINJECTION, SUSPENSION21
80777-400-62mNEXSPIKE1 in 1 CARTONINJECTION, SUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80777-400-17ML - Milliliter80777-4009315e167-00ef-4a5f-9cf8-28a99da640fb12025-09-12
80777-400-60ML - Milliliter80777-40034bf849f-2cb3-4db0-b7fc-f56caeab9c9e12025-09-12
80777-400-61ML - Milliliter80777-40026c5e500-aa89-4fae-a784-303faa9373b312025-09-12
80777-400-62ML - Milliliter80777-4004bdfa77b-7302-43a0-b716-b85d9bb8ac3012025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2722661mNEXSPIKE 2025-2026 vaccine, 0.2 ML Prefilled SyringePSN97c27eb6-1d2e-4953-afac-882ada70c6f81
2722654SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled SyringePSN97c27eb6-1d2e-4953-afac-882ada70c6f81
27226610.2 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.05 MG/ML Prefilled Syringe [Mnexspike 2025-2026]SBD97c27eb6-1d2e-4953-afac-882ada70c6f81
27226540.2 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.05 MG/ML Prefilled SyringeSCD97c27eb6-1d2e-4953-afac-882ada70c6f81
27226610.2 ML Mnexspike 2025-2026 0.05 MG/ML Prefilled SyringeSY97c27eb6-1d2e-4953-afac-882ada70c6f81
2722661mNEXSPIKE 2025-2026 vaccine, 0.2 ML Prefilled SyringeSY97c27eb6-1d2e-4953-afac-882ada70c6f81
2722654SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled SyringeSY97c27eb6-1d2e-4953-afac-882ada70c6f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80777-400-17807770400170.2 mL in 1 SYRINGE, PLASTIC0.2 mlHistorical
80777-400-608077704006010 SYRINGE, PLASTIC in 1 CARTON (80777-400-60) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17) 2025-08-27NoNoHistorical
80777-400-61807770400612 SYRINGE, PLASTIC in 1 CARTON (80777-400-61) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17) 2025-08-27NoNoHistorical
80777-400-62807770400621 SYRINGE, PLASTIC in 1 CARTON (80777-400-62) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17) 2025-08-27NoNoHistorical