Flucelvax (INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED,) by Seqirus Inc.: new vaccine listing
Flucelvax: new vaccine listing. Dated 126 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-11-03, 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 | Flucelvax |
| Generic name | INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Tasmania/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Arizona/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INAC |
| NDC | 70461-656 |
| Labeler | Seqirus Inc. |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125408 |
| Dosage form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL; INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL; INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL |
| Marketing start | 2026-07-01 |
| Package configurations | 1 |
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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: 2026-07-01
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:09:00 GMT
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Peer benchmark and outreach value: Flucelvax 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 Flucelvax?
Flucelvax by Seqirus Inc.: new vaccine listing (BLA) starting 2026-07-01.
How does Flucelvax compare to other FdaNdcDirectoryPulse records?
It is 126 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.
Flucelvax vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Flucelvax | VACCINE | 2026-07-01 |
| 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.