Spikevax (COVID-19 Vaccine, mRNA) by Moderna US, Inc.: new vaccine listing
Spikevax: new vaccine listing. Dated 80 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-11-04, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Free preview: all 12 published fields of this record are shown below. Locked: 17 related FdaNdcDirectoryPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Product | Spikevax |
| Generic name | COVID-19 Vaccine, mRNA |
| NDC | 80777-115 |
| Labeler | Moderna US, Inc. |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125752 |
| Dosage form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | CX-055611 25 ug/.25mL |
| Marketing start | 2026-08-17 |
| Package configurations | 1 |
| Peer records CSV (18 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Product · Labeler · Pathway · Form · Listed · official source URL
- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-08-17
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Wed, 04 Nov 2026 18:12:05 GMT
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Peer benchmark and outreach value: Spikevax and 18 VACCINE peers
- VACCINE FdaNdcDirectoryPulse records like this one: 18
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every VACCINE peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Launch Signal Score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.
What is the FdaNdcDirectoryPulse record for Spikevax?
Spikevax by Moderna US, Inc.: new vaccine listing (BLA) starting 2026-08-17.
How does Spikevax compare to other FdaNdcDirectoryPulse records?
It is 80 days old; check the official source for later updates before acting. Its Launch Signal Score of 80/100 puts it among the stronger signals in this feed.
Spikevax vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Spikevax | VACCINE | 2026-08-17 |
| Comirnaty | VACCINE | 2026-08-27 |
| NUVAXOVID 2026-27 | VACCINE | 2026-08-27 |
| Comirnaty | VACCINE | 2026-08-27 |
Related records
FdaNdcDirectoryPulse: Vaccine FdaNdcDirectoryPulse: Biologic (BLA)
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Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.