Vaccine · BLA
Fluzone Tiv Sh 2026 NDC 49281-626
Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients · Injection, Suspension · Intramuscular · Sanofi Vaccines US Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49281-626-50 | 4928106265049281062650 | 10 SYRINGE, GLASS in 1 PACKAGE (49281-626-50) / .5 mL in 1 SYRINGE, GLASS (49281-626-88)Marketed from Feb 20, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fluzone Tiv Sh 2026
- Generic name (nonproprietary)
- influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)
- Active ingredients
- Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) — 15 ug/.5mLInfluenza a virus a/singapore/gp20238/2024 ivr-277 (H3n2) antigen (Formaldehyde inactivated) — 15 ug/.5mLInfluenza b virus b/michigan/01/2021 antigen (Formaldehyde inactivated) — 15 ug/.5mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- Sanofi Vaccines US Inc.NDC labeler code 49281
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103914
- Marketing start
- Marketing end
- Identifiers
- Product ID 49281-626_5b401352-1683-4309-9708-b20472557a44SPL ID 5b401352-1683-4309-9708-b20472557a44
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N449281062650followed by a unit qualifier and the quantityPackage 49281-0626-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 49281-626
- What is NDC 49281-626?
- 49281-626 is the product NDC for Fluzone Tiv Sh 2026, Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients injection, suspension, listed with the FDA by Sanofi Vaccines US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluzone Tiv Sh 2026 (INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)).
- What is the active ingredient?
- Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated), Influenza a virus a/singapore/gp20238/2024 ivr-277 (H3n2) antigen (Formaldehyde inactivated), Influenza b virus b/michigan/01/2021 antigen (Formaldehyde inactivated).
- Who is the labeler?
- Sanofi Vaccines US Inc., NDC labeler code 49281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluzone Tiv Sh 2026?
- 1 other product NDC are listed under this name. See all Fluzone Tiv Sh 2026 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluzone Tiv Sh 2026 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluzone Tiv Sh 2026influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) | Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | 49281-315 | 49281-0315-15 |
Other NDCs under BLA 103914
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluzone HD Tiv Sh 2026influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) | Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 60 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | 49281-016 |
| Fluzone High Dose Northern Hemisphereinfluenza a virus a/switzerland/6849/2025 ivr-278 (a/missouri/11/2025 pdm09-like virus) (h1n1) antigen (formaldehyde inactivated), influenza a virus a/michigan/105/2025 san-049a (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/tokyo/eis13-175/2025 antigen (formaldehyde inactivated) | Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 60 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | 49281-126 |
| Fluzone High Dose Northern Hemisphereinfluenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) | Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated) 60 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Patheon Manufacturing Services LLC | 63552-722 |
| Fluzone Tiv Sh 2026influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) | Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | 49281-315 |
| Fluzone Trivalent Northern Hemisphereinfluenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/michigan/105/2025 san-049a (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/tokyo/eis13-175/2025 antigen (formaldehyde inactivated) | Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mg + 2 more ingredients | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | 49281-426 |
| Fluzone Trivalent Northern Hemisphereinfluenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/michigan/105/2025 san-049a (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/tokyo/eis13-175/2025 antigen (formaldehyde inactivated) | Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | 49281-645 |
| Fluzone Trivalent Northern Hemisphereinfluenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) | Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Bamboo US BidCo LLC | 83703-087 |