NDC codes

FDA NDC Directory
Product NDC (as listed)49281-315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49281-0315Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49281-315-1549281031515492810315151 VIAL, MULTI-DOSE in 1 PACKAGE (49281-315-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-315-78)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)
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 49281-315_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.

How CPT relates to drug billing

NDC on a medical claim

N449281031515 followed by a unit qualifier and the quantity

Package 49281-0315-15. 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 49281-315

What is NDC 49281-315?
49281-315 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluzone Tiv Sh 2026 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage 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 ingredientsInjection, SuspensionIntramuscularSanofi Vaccines US Inc.49281-62649281-0626-50

Other NDCs under BLA 103914

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103914
ProductStrengthForm · routeLabelerProduct 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 ingredientsInjection, SuspensionIntramuscularSanofi 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 ingredientsInjection, SuspensionIntramuscularSanofi 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 ingredientsInjection, SuspensionIntramuscularPatheon Manufacturing Services LLC63552-722
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 ingredientsInjection, SuspensionIntramuscularSanofi Vaccines US Inc.49281-626
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 ingredientsInjection, SuspensionIntramuscularSanofi 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 ingredientsInjection, SuspensionIntramuscularSanofi 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 ingredientsInjection, SuspensionIntramuscularBamboo US BidCo LLC83703-087

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