NDC 49281-0286-01 — DAPTACEL corynebacterium diphtheriae toxoid

🆔 Identity & classification

FDA NDC (as labeled) 49281-286-01

Product NDC 49281-286

11-digit billing NDC 49281028601

Application # BLA103666

SPL Set ID 06f34d0f-4e72-41d3-967f-8abf3f2005c1

Established class (EPC) Inactivated Bordetella Pertussis Vaccine; Inactivated Bordet

Physiologic effect Actively Acquired Immunity

Chemical class Diphtheria Toxoid

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2002-05-14

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 (

GCN Seq No 063687

GCN 99405

HICL code 035263

Ingredient (HICL) Diph,Pertuss(Acell),Tet Ped/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 80:08.00.00

AHFS class Toxoids

FDB label name DAPTACEL DTAP VACCINE

FDB brand name Daptacel Dtap

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 49281-286-01 — 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 → 49281-0286-01. 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.

🏭 Manufacturer & labeler

LabelerSanofi Vaccines US Inc.

FDA applicationBLA103666 (BLA)

Labeler code49281

First marketedMay 2002

Product typeVaccine

Portfolio27 products on file

🔎 All NDCs from Sanofi Vaccines US Inc.

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.

🩺 Clinical

Label name DAPTACEL DTAP VACCINE Ingredient Diph,Pertuss(Acell),Tet Ped/Pf

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 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.

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.
5 ug / 0.5 mL 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.
50 ng / 0.5 mL 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.
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 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.

5 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.

💲 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 system	Per mL	Per 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: 5 vials 10 vials

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Daptacel 15 [Lf]/.5mL; 5 [Lf]/.5mL; 10 ug/.5mLthis 49281-0286-01	Sanofi	1 vial	—	—	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

🏛️

2002

First FDA approval

May 2002

📍

2026

Currently FDA-listed

24 years listed

🧬

·

Biosimilars

see Purple Book

🧬Biologic — competition comes from biosimilars

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

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
49281-0286-01 You're viewing this	1 VIAL in 1 PACKAGE (49281-286-01) / .5 mL in 1 VIAL (49281-286-58)	2002-05-14	Active
49281-0286-05	5 VIAL in 1 PACKAGE (49281-286-05) / .5 mL in 1 VIAL (49281-286-58)	2002-05-14	Active
49281-0286-10	10 VIAL in 1 PACKAGE (49281-286-10) / .5 mL in 1 VIAL (49281-286-58)	2002-05-14	Active

Pack size FAQ

What quantity is in NDC 49281-0286-01?

NDC 49281-0286-01 contains 1 vial — 1 vial in 1 package / .5 ml in 1 vial.

What is the difference between NDC 49281-0286-01 and NDC 49281-0286-05?

Both are DAPTACEL corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen ( 15 [Lf]/.5mL; 5 [Lf]/.5mL; 10 ug/.5mL Injection, Suspension — the drug itself is identical. NDC 49281-0286-01 is the 1 vial package, while NDC 49281-0286-05 is the 5 vials package.

What NDC number is used to bill for this package of DAPTACEL corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen ( 15 [Lf]/.5mL; 5 [Lf]/.5mL; 10 ug/.5mL Injection, Suspension?

Bill NDC 49281-0286-01 — the 11-digit billing format is 49281028601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 49281-286-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49281-0286-01, written without dashes as 49281028601. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 49281-0286-01, the first segment (49281) is the labeler code FDA assigned to Sanofi Vaccines US Inc.; the middle segment (0286) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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 2 other package presentations of this same product, including 5 vials (49281-0286-05), 10 vials (49281-0286-10). 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.

📄 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 ↗

🔗 Related NDC lookups

🧪 All Corynebacterium Diphtheriae Toxoid Antigen (Formaldehyde Inactivated), Clostridium Tetani Toxoid Antigen (Formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (Glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen ( NDCsSame ingredient 🏭 All Sanofi labeler NDCsLabeler code 49281 📚 All Inactivated Bordetella Pertussis Vaccine NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Vaccine/Toxoid Preparations,Combinations.

Measles,Mumps,Rub,Varicella/Pf 00006-4171-00 Measles,Mumps,Rubella Vacc/Pf 00006-4681-00 Haemph B Polysac Conj-Menin/Pf 00006-4897-00 Tetanus, Diphtheria Tox,Adult 13533-0131-01 Tetanus-Diphtheria Toxoids/Pf 49281-0215-10 Tetanus,Diphtheria Toxd Ped/Pf 49281-0225-10 Diphth,Pertuss(Acell),Tet Ped 49281-0286-05 Diph,Pertuss(Acell),Tet Vac/Pf 49281-0400-10 Dipht,Pert(A),Tet-Polio/Hib/Pf 49281-0511-05 Haemoph B Poly Conj-Tet Tox/Pf 49281-0545-03 Diph,Pertus(Acel),Tet,Polio/Pf 49281-0562-10 Diphth,Pertuss(Acell),Tet Vac 50090-1377-00 Dip,Pert(A)Tet/Hepb/Pol/Hib/Pf 50090-7542-00

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.