mNEXSPIKE
- Product NDC
- 80777-401
- 11-digit product format
- 807770401
- Labeler code
- 80777
- Product ID
- 80777-401_d32253ba-dd1e-46ea-bbef-3eb1e135d91e
- 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
- 2026-08-17
- Substance
- CX-055610
- Active strength
- 10 ug/.2mL
- 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
- mNEXSPIKE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CX-055610 | 10 ug/.2mL |
DailyMed Product Concepts#
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125835 | mnexspike | COVID-19 Vaccine, mRNA | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80777-401-60 | 80777040160 | 10 SYRINGE, PLASTIC in 1 CARTON (80777-401-60) / .2 mL in 1 SYRINGE, PLASTIC (80777-401-17) | 2026-08-17 | No | No | Current |