mFLUSIVA
- Product NDC
- 80777-500
- 11-digit product format
- 807770500
- Labeler code
- 80777
- Product ID
- 80777-500_3dd1c6d2-b054-4803-bb21-460b1b090d4c
- Type
- VACCINE
- Nonproprietary name
- Influenza Vaccine, mRNA
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Moderna US, Inc.
- Application
- BLA125869
- Marketing category
- BLA
- Marketing start
- 2026-08-05
- Substance
- RNA-101-BFL3; RNA-101-BFL6; RNA-101-BFL5
- Active strength
- 12.5; 12.5; 12.5 ug/.38mL; ug/.38mL; ug/.38mL
- NDC exclude flag
- No
- 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
- mFLUSIVA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RNA-101-BFL3 | 12.5 ug/.38mL |
| RNA-101-BFL6 | 12.5 ug/.38mL |
| RNA-101-BFL5 | 12.5 ug/.38mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125869 | flusiva,mflusiva | Influenza Vaccine, mRNA | 351(a) | Rx | 2026-09-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80777-500-20 | 80777050020 | 10 SYRINGE, PLASTIC in 1 CARTON (80777-500-20) / .38 mL in 1 SYRINGE, PLASTIC (80777-500-18) | 2026-08-05 | No | No | Current |