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BAT Botulism Antitoxin Heptavalent 4500 [iU]/10mL; 3300 [iU]/10mL; 3000 [iU]/10mL; 600 [iU]/10mL Liquid, 20 mL — NDC 60492-0075-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BAT Botulism Antitoxin Heptavalent 4500 [iU]/10mL; 3300 [iU]/10mL; 3000 [iU]/10mL; 600 [iU]/10mL Liquid, 20 mL — NDC 60492-0075-3 (Billing 60492-0075-03)

by Emergent BioSolutions Canada Inc · 20 mL in 1 VIAL, GLASS

This is a package of 20 mL of BAT Botulism Antitoxin Heptavalent 4500 [iU]/10mL; 3300 [iU]/10mL; 3000 [iU]/10mL; 600 [iU]/10mL Liquid from Emergent BioSolutions Canada Inc, marketed since Mar 2013 and currently FDA-listed.

NDC 60492-0075-03
🏷️ FDA NDC (as labeled) 60492-0075-3 billing pads the package segment with a zero
This package
Contains20 mL Pack sizes3 compare ↓
Product page 60492-0075-02 Also comes in: 50 ml 60492-0075-2 50 ml 60492-0075-4
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 60492-0075-3 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
60492 labeler · 0075 product · 3 package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6049200753 7
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60492-0075-3
Product NDC 60492-0075
11-digit billing NDC 60492007503
Application # BLA125462
SPL Set ID 9f3c4292-8773-4781-8264-d71c80d3eabd
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-01
Route INTRAVENOUS
Dosage form LIQUID
Substance EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB
Biologic (Purple Book) 351(a)

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

GCN Seq No 071156
GCN 34860
HICL code 040449
Ingredient (HICL) Botulism Antitoxin 7/Maltose
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7K
Therapeutic class — specific (HIC3) Antisera
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name BOTULISM ANTITOXIN HEPTAV VIAL
FDB brand name Botulism Antitoxin Heptavalent
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071156
  • GCN: 34860
  • HICL (First Databank): 040449
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 60492-0075-3 — a 5-4-1 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 package segment → 60492-0075-03. 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 BOTULISM ANTITOXIN HEPTAV VIAL Ingredient Botulism Antitoxin 7/Maltose

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: 50 ml 50 ml
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
60492-0075-02 60492-0075-2 Main listing 50 mL in 1 VIAL, GLASS 2013-03-01 — Active
60492-0075-03 You're viewing this 20 mL in 1 VIAL, GLASS 2013-03-01 — Active
60492-0075-04 60492-0075-4 50 mL in 1 VIAL, GLASS 2013-03-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 20 mL — 20 ml in 1 vial, glass.
How does this package differ from NDC 60492-0075-02?
Both are BAT Botulism Antitoxin Heptavalent 4500 [iU]/10mL; 3300 [iU]/10mL; 3000 [iU]/10mL; 600 [iU]/10mL Liquid — the drug itself is identical. This page's package is the 20 mL one, while NDC 60492-0075-02 is the 50 ml package.
What NDC number is used to bill for this package of BAT Botulism Antitoxin Heptavalent 4500 [iU]/10mL; 3300 [iU]/10mL; 3000 [iU]/10mL; 600 [iU]/10mL Liquid?
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
Bat 4500 [iU]/10mL; 3300 [iU]/10mL; 3000 [iU]/10mL; 600 [iU]/10mLthis 60492-0075-03 Emergent 20 ml — — 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
Mar 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 Mar 2025 — those protections no longer apply, though a biosimilar still needs FDA licensure and a manufacturer to market it.
📅 FDA approved Mar 22, 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 dateMar 22, 2025
Common questions
Is there a biosimilar for BOTULISM ANTITOXIN HEPTAV 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.

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 DM477EE40D
    Maltose monohydrate is a sugar made from grain starch. It works as a sweetener, filler, and binder to give the medicine bulk, taste, and help hold ingredients together in tablets or capsules.
  • 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.

2 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

LabelerEmergent BioSolutions Canada Inc
FDA applicationBLA125462 (BLA)
Labeler code60492
First marketedMar 2013
Product typePlasma Derivative

More NDCs from Emergent BioSolutions Canada Inc labeler code 60492

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 Emergent BioSolutions Canada 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 50 ml (60492-0075-02), 50 ml (60492-0075-04). 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?
Emergent BioSolutions Canada 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.
← 60468-0007-03 · allphamed 60492-0173-02 · Emergent →
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.