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QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine 15 [Lf]/.5mL; 5 [Lf]/.5mL; 20 ug/.5mL Injection, Suspension, 10 vials — NDC 49281-0564-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine 15 [Lf]/.5mL; 5 [Lf]/.5mL; 20 ug/.5mL Injection, Suspension, 10 vials — NDC 49281-564-10 (Billing 49281-0564-10)

by Sanofi Vaccines US Inc. · 10 VIAL, SINGLE-USE in 1 PACKAGE / .5 mL in 1 VIAL, SINGLE-USE

This is a package of 10 vials of QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine 15 [Lf]/.5mL; 5 [Lf]/.5mL; 20 ug/.5mL Injection, Suspension from Sanofi Vaccines US Inc., marketed since Mar 2015 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 49281-0564-10
🏷️ FDA NDC (as labeled) 49281-564-10 billing pads the product segment with a zero
This package
Contains10 vials Pack sizes2 compare ↓
Main listing for product 49281-564 · Also comes in: 10 syringes 49281-564-15
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49281-564-10
Product NDC 49281-564
11-digit billing NDC 49281056410
NCPDP billing unit ML — per mL (volume)
Application # BLA125525
SPL Set ID 76798bc5-6752-4c02-9f03-68a361eea66b
Established class (EPC) Actively Acquired Immuni
Physiologic effect Actively Acquired Immunity
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-03-24
Route INTRAMUSCULAR
Dosage form INJECTION, SUSPENSION
Substance CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 18990004351820
GPI class Quadracel
GCN Seq No 083062
GCN 51903
HICL code 035666
Ingredient (HICL) Diph,Pertus(Acel),Tet,Polio/Pf
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7Z
Therapeutic class — specific (HIC3) Vaccine/Toxoid Preparations,Combinations
AHFS code 80:12.00.00
AHFS class Vaccines
FDB label name QUADRACEL DTAP-IPV VIAL
FDB brand name Quadracel Dtap-Ipv
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083062
  • GCN: 51903
  • GPI-14 (Medi-Span): 18990004351820
  • HICL (First Databank): 035666
  • AHFS class code: 80:12.00.00
Why two NDCs? The FDA registers this code as 49281-564-10 — 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 → 49281-0564-10. 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

Label name QUADRACEL DTAP-IPV VIAL Ingredient Diph,Pertus(Acel),Tet,Polio/Pf
📖 What it is MedlinePlus · NLM

Why get vaccinated? Diphtheria, tetanus, pertussis, and inactivated polio vaccine may prevent diphtheria, tetanus, pertussis, and poliomyelitis (polo) that may occur with infection due to C. diphtheriae (diphtheria), C. tetani (tetanus), B. pertussis (pertussis), and polioviruses. Infection with C. diphtheriae can cause diphtheria (difficulty breathing and life-threatening heart failure and paralysis), infection with C. tetani can cause tetanus (painful stiffening of the muscles), infection with B. pertussis can cause whooping cough (a respiratory disease with severe coughing episodes) and p...

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 mLPer 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.
Try another pack size: 10 syringes
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
49281-0564-10 You're viewing this Main listing 10 VIAL, SINGLE-USE in 1 PACKAGE / .5 mL in 1 VIAL, SINGLE-USE 2015-03-24 — Active
49281-0564-15 49281-564-15 10 SYRINGE in 1 PACKAGE / .5 mL in 1 SYRINGE 2015-03-24 — Active

Pack size FAQ

What quantity is in this package?
This package contains 10 vials — 10 vial, single-use in 1 package / .5 ml in 1 vial, single-use.
How does this package differ from NDC 49281-0564-15?
Both are QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine 15 [Lf]/.5mL; 5 [Lf]/.5mL; 20 ug/.5mL Injection, Suspension — the drug itself is identical. This page's package is the 10 vials one, while NDC 49281-0564-15 is the 10 syringes package.
What NDC number is used to bill for this package of QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine 15 [Lf]/.5mL; 5 [Lf]/.5mL; 20 ug/.5mL Injection, Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quadracel 15 [Lf]/.5mL; 5 [Lf]/.5mL; 20 ug/.5mLthis 49281-0564-10 Sanofi 10 vials — — 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

🏛️
2015
First FDA approval
Mar 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🧬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: FDA patent/protection data lists protections through Mar 2027. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 24, 2015 ⏳ ~0.5 yr to latest listed protection

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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
KinrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine QuadracelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2015 2017 2019 2021 2023 2025 2027
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 dateMar 24, 2027
Common questions
Is there a biosimilar for QUADRACEL DTAP-IPV VIAL?
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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 27432CM55Q
    Bovine albumin is a natural protein derived from cow blood. In medicines, it acts as a stabilizer and binder, helping preserve active ingredients and hold solid formulations together.
  • 1.5 mg / 0.5 mL UNII F92V3S521O
    Aluminum phosphate is an inorganic salt used in medications as a buffer and absorbent. It helps stabilize the product's pH and can absorb moisture or other substances in the formulation.
  • UNII 1HG84L3525
    Formaldehyde is a preservative chemical that prevents bacterial and fungal growth in medicines. It keeps the product safe and stable during storage by stopping contamination.
  • UNII T3C89M417N
    Glutaral is a chemical preservative that kills bacteria and fungi. It's used in some medicines to prevent microbial growth and extend shelf life, especially in liquid formulations.
  • UNII I16QD7X297
    Neomycin is an antibiotic substance. In topical medicines, it serves as an active antimicrobial agent rather than an inactive excipient, helping prevent bacterial infection in wounds or skin conditions.
  • 3.3 mg / 0.5 mL UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 19371312D4
    This is a naturally derived antibiotic that's added as a preservative and antimicrobial agent to prevent bacterial growth in the medicine, particularly in sterile injectable or ophthalmic products.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII CW25IKJ202
    Streptomycin sulfate is an antibiotic salt used as a preservative in some injectable medicines to prevent bacterial and fungal growth during storage.
  • 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.

10 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 applicationBLA125525 (BLA)
Labeler code49281
First marketedMar 2015
Product typeVaccine
Portfolio27 products on file
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: this package is listed as actively marketed, with no marketing end date reported by Sanofi Vaccines US Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 syringes (49281-0564-15). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 49281-0545-03 · Sanofi 49281-0574-15 · 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.