Home › NDC Lookup › Ingredients › Influenza A Virus A/Missouri/11/2025 (H1... › 49281-0726-10
FLUBLOK TRIVALENT NORTHERN HEMISPHERE INFLUENZA A VIRUS A/Missouri/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/Darwin/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/Pennsylvania/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug/.5mL; 45 ug/.5mL Injection, 10 syringes — NDC 49281-0726-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FLUBLOK TRIVALENT NORTHERN HEMISPHERE INFLUENZA A VIRUS A/Missouri/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/Darwin/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/Pennsylvania/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug/.5mL; 45 ug/.5mL Injection, 10 syringes — NDC 49281-726-10 (Billing 49281-0726-10)

by Sanofi Vaccines US Inc. · 10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

This is a package of 10 syringes of FLUBLOK TRIVALENT NORTHERN HEMISPHERE INFLUENZA A VIRUS A/Missouri/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/Darwin/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/Pennsylvania/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug/.5mL; 45 ug/.5mL Injection from Sanofi Vaccines US Inc., marketed since Jul 2026 and currently FDA-listed, this package's marketing is listed to end Jun 2027. It is this product's only package size.

NDC 49281-0726-10
🏷️ FDA NDC (as labeled) 49281-726-10 billing pads the product segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 49281-726-10 alone.

Record
FDA NDC Directory package listing · Vaccine
Code segments
49281 labeler · 726 product · 10 package
Package marketed since
Jul 2, 2026
Package marketing ended
Jun 30, 2027
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 4928172610 1
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49281-726-10
Product NDC 49281-726
11-digit billing NDC 49281072610
NCPDP billing unit ML — per mL (volume)
Application # BLA125285
SPL Set ID 0c3cd915-babe-49c0-8aac-bf0247a17f3e
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-02
Marketing end 2027-06-30
Route INTRAMUSCULAR
Dosage form INJECTION
Substance INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 49281-726-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49281-0726-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📖 What it is MedlinePlus · NLM

Why get vaccinated? Influenza vaccine, inactivated or recombinant may prevent influenza illness (flu) that may occur with infection due to the influenza virus. Flu is a contagious disease that spreads around the United States every year, usually between October and May. Anyone can get the flu, but it is more dangerous for some people. Flu can cause fever and chills, sore throat, muscle aches, fatigue, cough, headache, and runny or stuffy nose. Flu can cause other complications such as sinus infections and pneumonia and can lead to hospitalization and death. Influenza vaccine, inactivated or r...

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49281-0726-10 You're viewing this Main listing 10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE 2026-07-02 Jun 30, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Flublok Trivalent Northern Hemisphere 45 ug/.5mL; 45 ug/.5mLthis 49281-0726-10 Sanofi 10 syringes — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2013
First FDA approval
Jan 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Biosimilar pathway open
listed protections lapsed 2025
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jan 2025 — those protections no longer apply, though a biosimilar still needs FDA licensure and a manufacturer to market it.
📅 FDA approved Jan 16, 2013

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2013 2015 2017 2019 2021 2023 2025
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJan 16, 2025
Common questions
Is there a biosimilar for this drug?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7JPC6Y25QS
    A synthetic nonionic surfactant, a type of cleaning agent used in pharmaceutical formulations. It functions as an emulsifier and solubilizer, helping mix water and oil-based ingredients and improving how the medicine dissolves and spreads in the body.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII E1W4N241FO
    A salt compound derived from phosphoric acid and sodium, used as a buffer to help maintain the medication's pH level and as a filler to give the tablet or capsule its proper form and size.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSanofi Vaccines US Inc.
FDA applicationBLA125285 (BLA)
Labeler code49281
First marketedJul 2026
Product typeVaccine
Portfolio27 products on file

More NDCs from Sanofi Vaccines US Inc. labeler code 49281

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Sanofi Vaccines US Inc. has reported a marketing end date of 2027-06-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sanofi Vaccines US Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 49281-0725-10 · Sanofi 49281-0752-21 · Sanofi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.