Moderna COVID-19 Vaccine
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE: EMERGENCY USE AUTHORIZATION OF MODERNA COVID-19 VACCINE (2024-2025 FORMULA), FOR INDIVIDUALS 6 MONTHS THROUGH 11 YEARS OF AGE
Approved
Approval ID
530786f0-58d9-4370-88f0-6e98e4b85183
Product Type
VACCINE LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
Moderna US, Inc.
DUNS: 117626450
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Moderna COVID-19 Vaccine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80777-287
Product Classification
G
Generic Name
Moderna COVID-19 Vaccine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (11)
TROMETHAMINE HYDROCHLORIDEInactive
Code: 383V75M34E
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
CX-038839 OMICRON (XBB.1.5)Active
Quantity: 25 ug in 0.25 mL
Code: 4F9QRS7ZV2
Classification: ACTIB
SM-102Inactive
Code: T7OBQ65G2I
Classification: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7J
Classification: IACT
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINEInactive
Code: 043IPI2M0K
Classification: IACT
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000Inactive
Code: 9X2596CIE0
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Moderna COVID-19 Vaccine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80777-291
Product Classification
G
Generic Name
Moderna COVID-19 Vaccine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (11)
CX-046684Active
Quantity: 25 ug in 0.25 mL
Code: KCK3ADW2DH
Classification: ACTIB
SM-102Inactive
Code: T7OBQ65G2I
Classification: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7J
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
TROMETHAMINE HYDROCHLORIDEInactive
Code: 383V75M34E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINEInactive
Code: 043IPI2M0K
Classification: IACT
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000Inactive
Code: 9X2596CIE0
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT