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Epinephrine Professional Epinephrine and Isopropyl Alcohol Kit — NDC 24357-0011-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Epinephrine Professional Epinephrine and Isopropyl Alcohol Kit — NDC 24357-011-13 (Billing 24357-0011-13)

by Focus Health Group · 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 PACKET

This is a package of Epinephrine Professional Epinephrine and Isopropyl Alcohol Kit from Focus Health Group, marketed since Jul 2019 and currently FDA-listed. It is this product's only package size.

NDC 24357-0011-13
🏷️ FDA NDC (as labeled) 24357-011-13 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 24357-011-13 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24357 labeler · 011 product · 13 package
Package marketed since
Jul 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 2435701113 8
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class III · Mar 16, 2023 — Labeling; Incorrect NDC number on outer carton of product. (Focus Health Group Inc) · FDA recall D-0535-2023
Lots / codes: Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024 · reported Apr 19, 2023
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24357-011-13
Product NDC 24357-011
11-digit billing NDC 24357001113
NCPDP billing unit EA — each (per item)
RxCUI 797544, 1660014, 1660016
Application # NDA204200
SPL Set ID 8c502fcc-1b61-7d1f-e053-2a95a90adc46
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-01
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form KIT
TE code (Orange Book) AP · RLD · RS

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

GPI-14 38900040006420
GPI class Epinephrine Professional
GCN Seq No 074866
GCN 39693
HICL code 002050
Ingredient (HICL) Epinephrine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5F
Therapeutic class — specific (HIC3) Anaphylaxis Therapy Agents
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name EPINEPHRINE PROFESSIONAL KIT
FDB brand name Epinephrine Professional Kit
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 074866
  • GCN: 39693
  • GPI-14 (Medi-Span): 38900040006420
  • HICL (First Databank): 002050
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 797544
Why two NDCs? The FDA registers this code as 24357-011-13 — 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 → 24357-0011-13. 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.

RxNorm drug class

This medicine belongs to the Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name EPINEPHRINE PROFESSIONAL KIT Ingredient Epinephrine
📖 What it is MedlinePlus · NLM

Epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine injection is also used to treat life-threatening low blood pressure associated with septic shock (a serious condition caused by a body-wide infection that can lead to dangerously low blood pressure and organ failure) in hospitalized patients. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the ai...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Use it at the first signs of a severe allergic reaction (anaphylaxis), such as trouble breathing, swelling, hives, vomiting or feeling faint. It is for emergencies, so don't wait t...
  • For AUVI-Q, inject into the outer thigh, through clothing if needed. Never inject it into a vein, your buttock, or your fingers, hands or feet. In young children, hold the leg firm...
  • Yes. Epinephrine is emergency treatment only, not a substitute for medical care. You need monitoring, and you may need more treatment. If symptoms don't improve, a second dose can...
  • Do I still need to go to the hospital after using it?
📖 Read our full Epinephrine Injection guide →

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.
Medicare Part B allowsASP · J0169 $0.783 / J0169 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)24357-011-13
11-digit billing NDC24357-0011-13
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0169
DescriptorINJECTION, EPINEPHRINE (ADRENALIN), NOT THERAPEUTICALLY EQUIVALENT TO J0165, 0.1 MG
Billing units / pkg10 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 0.1 MG, so one package = 10 billing units.
Medicare Part B spend (2026 (Q1))$1,578 · 184 claims · $8.57 per claim (all NDCs under J0169)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24357-0011-13 You're viewing this Main listing 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 PACKET 2019-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adrenalin 1 mg/mL 42023-0159-25 Par 25 vials $7.796 AP Availability likely —
Epinephrine 1 mg/mL 00143-9476-25 Hikma 25 ampules — AP FDA listed —
Adrenalin 1 mg/mL 00404-9810-01 Henry 1 vial — AP FDA listed —
Epinephrine 1 mg/mL 00404-9857-01 Henry 1 ampule — AP FDA listed —
epinephrine 1 mg/mL 00517-1171-10 American 10 ampules — — FDA listed —
Epinephrine Professionalthis 24357-0011-13 Focus 1 kit — AP FDA listed —
epinephrine 1 mg/mL 43066-0803-25 Baxter 25 vials — — FDA listed —
Epinephrine 1 mg/mL 50090-3039-00 A-S 25 ampules — AP Discontinued —
Adrenalin (Epinephrine) 1 mg/mL 51662-1290-01 HF 1 ml — AP FDA listed —
Epinephrine Convenience Kit 51662-1507-01 HF 1 vial — AP FDA listed —
Epinephrine 1 mg/mL 54288-0103-10 BPI 10 ampules — AP FDA listed —
Epinephrine 1 mg/mL 54288-0119-10 BPI 10 vials — AP FDA listed —
Epinephrine 1 mg/mL 63323-0696-25 Fresenius 25 vials — AP FDA listed —
epinephrine 1 mg/mL 68083-0591-10 Gland 10 ampules — AP FDA listed —
epinephrine 1 mg/mL 68462-0933-10 GLENMARK 10 ampules — AP FDA listed —
Adrenalin Vials 1 mg/mL 70385-2024-02 Sina 2 vials — AP FDA listed —
Adrenalin 1 mg/mL 70518-1342-00 REMEDYREPACK 25 vials — AP Discontinued —
Epinephrine 1 mg/mL 70518-4156-00 REMEDYREPACK 25 vials — AP FDA listed —
Epinephrine 1 mg/mL 70518-4274-00 REMEDYREPACK 25 vials — AP FDA listed —
Epinephrine 1 mg/mL 71872-7117-01 Medical 1 ampule — AP FDA listed —
Adrenalin 1 mg/mL 71872-7223-01 Medical 1 vial — AP FDA listed —
Epinephrine 1 mg/mL 71872-7360-01 Medical 1 vial — AP FDA listed —
Epinephrine 1 mg/mL 72572-0235-25 CIVICA, 25 vials — AP Discontinued —
Epinephrine 1 mg/mL 80830-1659-02 Amneal 25 vials — AP FDA listed —
Epinephrine 1 mg/mL 84549-0103-10 ProPharma 1 ml — AP FDA listed —
Adrenalin 1 mg/mL 84549-0159-25 ProPharma 1 ml — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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 & generic status

🏛️
2012
First FDA approval
Dec 2012
📍
2026
Currently FDA-listed
14 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 7, 2012 AP TE-rated RLD RS ⏳ ~8.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9295657 — method of use (U-1829)
US 9119876 — drug product
US 12280024 — drug product
2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 9295657 ↗ Method of use U-1829 Mar 13, 2035
US 9119876 ↗ Drug product — Mar 13, 2035
US 12280024 ↗ Drug product — Mar 13, 2035
Common questions
Is there a generic version of EPINEPHRINE PROFESSIONAL KIT?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for EPINEPHRINE PROFESSIONAL KIT. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerFocus Health Group
Application holderPH HEALTH LTD
FDA applicationNDA204200 (NDA)
Labeler code24357
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Focus Health Group labeler code 24357

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 prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
⏱️ Dosage and Administration 📄 Package Label / Principal Display Panel
⏱️ Dosage and Administration 69 words ▾

For treating anaphylaxis: Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5 ml) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary. Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 ml/kg), up to 0.3 mg (0.3 ml), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary.

📄 Package Label / Principal Display Panel 6 words ▾

Principal Display Panel Principal Display Panel

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

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 Focus Health Group. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Focus Health Group 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0169 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 24338-0856-03 · Azurity 24357-0300-01 · Focus →
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.