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EPIPEN JR epinephrine .15 mg/.3mL Injection — NDC 49502-0501-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EPIPEN JR epinephrine .15 mg/.3mL Injection — NDC 49502-501-02 (Billing 49502-0501-02)

by Viatris Specialty LLC · 2 CONTAINER in 1 CARTON / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS

This is a package of EPIPEN JR epinephrine .15 mg/.3mL Injection from Viatris Specialty LLC, marketed since Dec 1987 and currently FDA-listed; retail pharmacies pay about $290.64 per unit (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 49502-0501-02
🏷️ FDA NDC (as labeled) 49502-501-02 billing pads the product segment with a zero
This package
Contains.3 mL in 1 syringe, glass Cost per ea$290.64 NADAC Per package$581.28 / 2 syringes Pack sizes2 compare ↓
Also priced by: Medicaid pays $165.19/unit — full pricing hub ↓
Main listing for product 49502-501 · Also comes in: 1 syringe 49502-501-92
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 49502-501-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
49502 labeler · 501 product · 02 package
Package marketed since
Dec 22, 1987
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4950250102 9
Medicaid fills, this package
766 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Epinephrine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · May 14, 2026 — Failed Impurities/Degradations Specifications (Fresenius Kabi USA, LLC) · FDA recall D-0581-2026
Class II · Apr 1, 2026 — Lack of Assurance of Sterility (International Medication Systems Ltd.) · FDA recall D-0483-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (2)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-0993-2022
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1012-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49502-501-02
Product NDC 49502-501
11-digit billing NDC 49502050102
NCPDP billing unit EA — each (per item)
RxCUI 727316, 727347, 727386, 1870207
UNII YKH834O4BH
Application # NDA019430
SPL Set ID 7560c201-9246-487c-a13b-6295db04274a
Established class (EPC) alpha-Adrenergic Agonist; beta-Adrenergic Agonist; Catecholamine
Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Agonists
Chemical class Catecholamines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-12-22
Route INTRAMUSCULAR
Dosage form INJECTION
Substance EPINEPHRINE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 3890004000D520
GPI class EpiPen Jr 2-Pak
GCN Seq No 016878
GCN 19861
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 EPIPEN JR 2-PAK 0.15 MG INJCTR
FDB brand name Epipen Jr 2-Pak
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016878
  • GCN: 19861
  • GPI-14 (Medi-Span): 3890004000D520
  • HICL (First Databank): 002050
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 727316
Why two NDCs? The FDA registers this code as 49502-501-02 — 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 → 49502-0501-02. 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 alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Catecholamine
Drug family (ATC) Other agents for local oral treatment, Local hemostatics, Adrenergic and dopaminergic agents
How it works Adrenergic alpha-Agonists, Adrenergic beta-Agonists
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 EPIPEN JR 2-PAK 0.15 MG INJCTR Ingredient Epinephrine
📗 Our plain-language guide HelloPharmacist
  • Epinephrine works fast but wears off quickly — sometimes in as little as 15 to 20 minutes. Anaphylaxis can come back (this is called a biphasic reaction), and you may need addition...
  • Why do I need to go to the ER after using my EpiPen or Auvi-Q if I already feel better?
  • Yes, it absolutely matters. Inject into the outer thigh — you can even go through your clothing if needed. Never inject into the buttocks (that spot carries a risk of serious infec...
  • Where exactly do I inject it, and does it matter?
📖 Read our full Epinephrine guide →
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 eaPer package
Retail pharmacies payNADAC · weekly $290.638 $581.28 / 2 syringes
Medicaid paysCMS SDUD · 12 mo $165.19 $330.37 / 2 syringes
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Aug 2021 Jul 2022 May 2023 Mar 2025 $291.736 $290.638
Flat over the last 4 months.
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 Per unit Per pack Marketing startMarketing endStatus
49502-0501-02 You're viewing this Main listing 2 CONTAINER in 1 CARTON / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS $290.64 / ea $581.28 1987-12-22 — Active
49502-0501-92 49502-501-92 2 CONTAINER in 1 CARTON / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS Sample — — 1987-12-22 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 container in 1 carton / 1 syringe, glass in 1 container / .3 ml in 1 syringe, glass.
What NDC number is used to bill for this package of EPIPEN JR epinephrine .15 mg/.3mL Injection?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Epinephrine .5 mg/mL 00093-5985-27 Teva 1 syringe $129.053 — Availability likely save 56%
Epinephrine .15 mg/.3mL 49502-0101-02 Viatris 1 syringe $141.882 AB Availability likely save 51%
Epipen Jr .15 mg/.3mLthis 49502-0501-02 Viatris 1 syringe $290.638 AB FDA listed —
Epinephrine .15 mg/.3mL 50090-5254-00 A-S 1 ml — AB FDA listed —
Epinephrine .15 mg/.3mL 63629-8801-01 Bryant 1 syringe — AB FDA listed —
Epinephrine 0.15 Pediatrics .15 mg/.3mL 70385-2020-01 Sina 1 syringe — AB FDA listed —
Epinephrine .15 mg/.3mL 71872-7134-01 Medical 1 syringe — AB FDA listed —
Epinephrine .15 mg/.3mL 51662-1225-01 HF 1 syringe — AB 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

🏛️
1987
On the market since
Dec 1987
📍
2026
Currently FDA-listed
39 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒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.

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.

🧪 Avoiding an ingredient? See Epinephrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • 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.

4 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

LabelerViatris Specialty LLC
Application holderVIATRIS SPECIALTY LLC
FDA applicationNDA019430 (NDA)
Labeler code49502
First marketedDec 1987
Product typeHuman Prescription Drug
Portfolio120 products on file

More NDCs from Viatris Specialty LLC labeler code 49502

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 187 words ▾

1 INDICATIONS AND USAGE EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care. EpiPen and EpiPen Jr are non-selective alpha and beta-adrenergic receptor agonist indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Patients greater than or equal to 30 kg (66 lbs): EpiPen 0.3 mg ( 2 ) • Patients 15 to 30 kg (33 lbs to 66 lbs): EpiPen Jr 0.15 mg ( 2 ) Inject intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-dose injection . ( 2 )

2.1Recommended Dosage According to Patient Body Weight • Patients greater than or equal to 30 kg (approximately 66 pounds or more): EpiPen 0.3 mg • Patients 15 kg to 30 kg (33 pounds to 66 pounds): EpiPen Jr 0.15 mg

2.2Administration Instructions • Inject the single-dose EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Do not inject intravenously, and do not inject into buttocks, into digits, hands or feet [see Warnings and Precautions (5.2) ]. • Instruct caregivers of young children who are prescribed an EpiPen or EpiPen Jr and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2) ] . • Each EpiPen or EpiPen Jr is a single-dose epinephrine injection for single use.

Since the doses of epinephrine delivered from EpiPen or EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. • With severe persistent anaphylaxis, repeat injections with an additional EpiPen or EpiPen Jr may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1) ] . • The epinephrine solution in the clear window of the EpiPen or EpiPen Jr Auto-Injector should be inspected visually for particulate matter and discoloration.

Discarding After Use: The EpiPen and EpiPen Jr each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation, but is not available for future use, and should be discarded .

💊 Dosage Forms and Strengths 61 words ▾

3 DOSAGE FORMS AND STRENGTHS • Injection: 0.3 mg (0.3 mg/0.3 mL), clear and colorless solution in single-dose pre-filled auto-injector • Injection: 0.15 mg (0.15 mg/0.3 mL), clear and colorless solution in single-dose pre-filled auto-injector • Injection: 0.3 mg (0.3 mg/0.3 mL) single-dose pre-filled auto-injector ( 3 ) • Injection: 0.15 mg (0.15 mg/0.3 mL) single-dose pre-filled auto-injector ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • In conjunction with use, seek immediate medical or hospital care. ( 5.1 ) • Do not inject intravenously, into buttock, or into digits, hands, or feet. ( 5.2 ) • To minimize the risk of injection related injury, hold the child’s leg firmly in place and limit movement prior to and during injection when administering to young children.

( 5.2 ) • Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop signs or symptoms of infection. ( 5.3 ) • The presence of a sulfite in this product should not deter use.

( 5.4 ) • Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ( 5.5 )

5.1Emergency Treatment EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [ see Indications and Usage (1) , Dosage and Administration (2) and Patient Counseling Information (17) ].

5.2Injection-Related Complications EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh [ see Dosage and Administration (2) and Patient Counseling Information (17) ]. Do not inject intravenously Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.

Do not inject into buttock Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with Clostridial infections (gas gangrene).

Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower this risk. Do not inject into digits, hands or feet Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection.

Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [ see Adverse Reactions (6) ]. Hold leg firmly during injection Lacerations, bent needles, and embedded needles have been reported when EpiPen and EpiPen Jr have been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering, hold the child’s leg firmly in place and limit movement prior to and during injection.

5.3Serious Infections at the Injection Site Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores.

To decrease the risk of Clostridium infection, do not inject EpiPen into the buttock [see Warnings and Precautions (5.2) ]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.

5.4Allergic Reactions Associated with… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below. Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties.

These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [ see Warnings and Precautions (5.5) ]. Cardiovascular Reactions • Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [ see Warnings and Precautions (5.5) and Drug Interactions (7) ]. • Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see Warnings and Precautions (5.5) ]. • Angina may occur in patients with coronary artery disease [ see Warnings and Precautions (5.5) ]. • Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

Reactions from Accidental Injection and/or Improper Technique • Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [ see Warnings and Precautions (5.2) ]. • Adverse reactions experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury. • Lacerations, bent needles, and embedded needles have been reported when EpiPen has been injected into the thigh of young children who are uncooperative and kick or move during the injection [ see Warning and Precautions (5.2) ]. • Injection into the buttock has resulted in cases of gas gangrene [ see Warnings and Precautions (5.2) ] .

Skin and Soft Tissue Infections • Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection, including EpiPen, in the thigh [ see Warnings and Precautions (5.3) ]. Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 190 words ▾

7 DRUG INTERACTIONS Cardiac Glycosides, Diuretics, and Anti-arrhythmics Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5) ] . Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

Beta-Adrenergic Blockers The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol. Alpha-Adrenergic Blockers The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine. Ergot Alkaloids Ergot alkaloids may also reverse the pressor effects of epinephrine. • Cardiac glycosides or diuretics: observe for development of cardiac arrhythmias.

( 7 ) • Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines potentiate effects of epinephrine. ( 7 ) • Beta-adrenergic blocking drugs antagonize cardiostimulating and bronchodilating effects of epinephrine. ( 7 ) • Alpha-adrenergic blocking drugs antagonize vasoconstricting and hypertensive effects of epinephrine.

( 7 ) • Ergot alkaloids may reverse the pressor effects of epinephrine. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Elderly patients may be at greater risk of developing adverse reactions. ( 5.5 , 8.5 )

8.1Pregnancy Risk Summary There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. In animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m 2 basis. Epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans.

Epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate.

The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. Management of anaphylaxis during pregnancy is similar to management in the general population. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients.

In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Data Animal Data In an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). In an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days).

These effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).

8.2Lactation Risk Summary There is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients.

8.4Pediatric Use EpiPen or EpiPen Jr may be administered to pediatric patients at a dosage appropriate to body weight [ see Dosage and Administration (2.1) ] . Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the doses of epinephrine delivered from EpiPen and EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

8.5Geriatric Use Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. In animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m 2 basis. Epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans.

Epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate.

The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. Management of anaphylaxis during pregnancy is similar to management in the general population. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients.

In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Data Animal Data In an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). In an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days).

These effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).

🧒 Pediatric Use 86 words ▾

8.4Pediatric Use EpiPen or EpiPen Jr may be administered to pediatric patients at a dosage appropriate to body weight [ see Dosage and Administration (2.1) ] . Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the doses of epinephrine delivered from EpiPen and EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

🧓 Geriatric Use 90 words ▾

8.5Geriatric Use Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, EpiPen should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see Warnings and Precautions (5.5) , Overdosage (10) ].

🆘 Overdosage 145 words ▾

10 OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block.

Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol. Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

🧬 Clinical Pharmacology 119 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Epinephrine acts on both alpha- and beta-adrenergic receptors.

12.2Pharmacodynamics Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis. Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

🧬 Mechanism of Action 12 words ▾

12.1Mechanism of Action Epinephrine acts on both alpha- and beta-adrenergic receptors.

📦 How Supplied / Storage and Handling 168 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied • EpiPen 2-Pak (epinephrine) injection is supplied with 2 single-dose pre-filled auto-injectors and 1 auto-injector trainer device: 0.3 mg/0.3 mL (NDC 49502-500-02) • EpiPen Jr 2-Pak (epinephrine) injection is supplied with 2 single-dose pre-filled auto-injectors and 1 auto-injector trainer device: 0.15 mg/0.3 mL (NDC 49502-501-02) EpiPen 2-Pak ® and EpiPen Jr 2-Pak ® also include an S-clip to clip two carrier tubes together. Storage and Handling • Protect from light.

Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. • Do not refrigerate. • Before using, check to make sure the solution in the auto-injector is clear and colorless. • Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particle. • Properly dispose all used, unwanted or expired EpiPen and EpiPen Jr auto-injectors.

📋 Description ~1 min read ▾

11 DESCRIPTION EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution.

Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection.

The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure: Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.

Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [ see Patient Counseling Information (17) ]. Epinephrine Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling ( Error! Hyperlink reference not valid. ) A healthcare provider should review the patient instructions and operation of EpiPen and EpiPen Jr in detail, with the patient or caregiver. Epinephrine is essential for the treatment of anaphylaxis.

Patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used. Administration Instruct patients and/or caregivers in the appropriate use of EpiPen and EpiPen Jr. EpiPen should be injected into the middle of the outer thigh (through clothing, if necessary).

Each device is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of EpiPen. Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection.

Lacerations, bent needles, and embedded needles have been reported when EpiPen and EpiPen Jr have been injected into the thigh of young children who are uncooperative and kick or move during an injection [ see Warnings and Precautions (5.2) ]. Instruct patients and/or caregivers to throw away the blue safety release immediately after using EpiPen and EpiPen Jr. This small part may pose a choking hazard for children.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each EpiPen or EpiPen Jr carton. A printed label on the surface of EpiPen shows instructions for use and a diagram depicting the injection process. Training Instruct patients and/or caregivers to use and practice with the Trainer to familiarize themselves with the use of EpiPen in an allergic emergency.

The Trainer may be used multiple times. A Trainer device is provided in 2-Pak cartons. Instruct patients and/or caregivers to immediately place the blue safety release back on the Trainer and reset it after practicing.

This small part may pose a choking hazard for children. Adverse Reactions Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet and recumbency.

Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson’s disease may notice a temporary worsening of symptoms [ see Warnings and Precautions (5.5) ] .

Accidental Injection Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment should be directed at vasodilatation if there is such an accidental injection to these areas [ see Warnings and Precautions (5.2) ]. Serious Infections at the Injection Site Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis.

Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [ see Warnings and Precautions (5.3) ]. Storage and Handling Instruct patients to inspect the epinephrine solution visually through the clear window of the auto-injector periodically. Replace EpiPen and EpiPen Jr if the epinephrine solution appears… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 104 words ▾

12.2Pharmacodynamics Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis. Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

🧪 Nonclinical Toxicology 135 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro . Epinephrine was positive in the Salmonella bacterial reverse mutation assay, positive in the mouse lymphoma assay, and negative in the in vivo micronucleus assay.

Epinephrine is an oxidative mutagen based on the E. coli WP2 Mutoxitest bacterial reverse mutation assay. This should not prevent the use of epinephrine where indicated [see Indications and Usage (1) ]. The potential for epinephrine to impair reproductive performance has not been evaluated, but epinephrine has been shown to decrease implantation in female rabbits dosed subcutaneously with 1.2 mg/kg/day (40-fold the highest human intramuscular or subcutaneous daily dose) during gestation days 3 to 9.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 132 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro . Epinephrine was positive in the Salmonella bacterial reverse mutation assay, positive in the mouse lymphoma assay, and negative in the in vivo micronucleus assay.

Epinephrine is an oxidative mutagen based on the E. coli WP2 Mutoxitest bacterial reverse mutation assay. This should not prevent the use of epinephrine where indicated [see Indications and Usage (1) ]. The potential for epinephrine to impair reproductive performance has not been evaluated, but epinephrine has been shown to decrease implantation in female rabbits dosed subcutaneously with 1.2 mg/kg/day (40-fold the highest human intramuscular or subcutaneous daily dose) during gestation days 3 to 9.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION and INSTRUCTIONS FOR USE EPIPEN ® [/epeepen/] (epinephrine injection, USP) Auto-Injector 0.3 mg EpiPen ® = one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL EPIPEN JR ® [/epeepen/ /joonyer/] (epinephrine injection, USP) Auto-Injector 0.15 mg EpiPen Jr ® = one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL For allergic emergencies (anaphylaxis) PATIENT INFORMATION Read this Patient Information leaflet carefully before using the EpiPen ® or EpiPen Jr ® auto-injector and each time you get a refill.

There may be new information. Anyone who may be able to administer the EpiPen or EpiPen Jr auto-injector should know how to use it before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about EpiPen and EpiPen Jr? 1. EpiPen and EpiPen Jr are single-dose automatic injection devices (auto-injectors) that contain epinephrine.

Epinephrine is a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and can happen within minutes. If untreated, anaphylaxis can lead to death.

This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Symptoms of anaphylaxis may include: • trouble breathing • wheezing • hoarseness (changes in the way your voice sounds) • hives (raised reddened rash that may itch) • severe itching • swelling of your face, lips, mouth, or tongue • skin rash, redness, or swelling • fast heartbeat • weak pulse • feeling very anxious • confusion • stomach pain • losing control of urine or bowel movements (incontinence) • diarrhea or stomach cramps • dizziness, fainting, or “passing out” (unconsciousness) • Always carry 2 EpiPen or 2 EpiPen Jr auto-injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.

You also need to always carry 2 auto-injectors with you if the first auto-injector is activated before the dose can be given. A device that has been activated by accident cannot be used in an allergic emergency (anaphylaxis). Note: The EpiPen or EpiPen Jr auto-injector has been activated when the blue safety top is removed and a “pop” is heard, the orange needle end of the auto-injector is extended, or the medicine viewing window is blocked.

You may not know when anaphylaxis will happen. Talk to your healthcare provider if you need more auto-injectors to keep at work, school, or other locations. If you use 1 EpiPen or 1 EpiPen Jr to treat an emergency allergic reaction, be sure to replace it so you always carry 2 auto-injectors.

Tell your family members, caregivers, and others where you keep your EpiPen or EpiPen Jr auto-injectors. Make sure they know how to use it before you need it. You may be unable to speak in an allergic emergency. • When you have an allergic emergency (anaphylaxis) use your EpiPen or EpiPen Jr auto-injector right away.

Get emergency medical help right away even if you have used the EpiPen or EpiPen Jr auto-injector. You can use a second EpiPen or EpiPen Jr auto-injector if symptoms continue or come back or if the first auto-injector is activated before the dose can be given. For this reason, you should carry 2 EpiPen or 2 EpiPen Jr auto-injectors with you at all times.

If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider. What are EpiPen and EpiPen Jr auto-injectors? • EpiPen and EpiPen Jr auto-injectors are disposable, prefilled auto-injectors used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. Each device contains one dose of epinephrine. • EpiPen and EpiPen Jr auto-injectors are for immediate administration by you or your caregiver.

They do not take the place of emergency medical care. You… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL – 0.3 mg EPIPEN 2-PAK ® (epinephrine injection, USP) Single-Dose Auto-Injector 0.3 mg For Allergic Emergencies (Anaphylaxis) NDC 49502-500-02 This carton contains: Two EpiPen® in protective cases Patient Information Leaflet & Trainer Instructions for Use One gray Trainer The EpiPen auto-injector and Trainer are not toys and should be used under adult supervision. Never put thumb, fingers or hand over orange needle end. Do not remove blue safety top until ready to use.

EpiPen 2-Pak ® contains 2 EpiPen ® auto-injectors and 1 Trainer. Each EpiPen ® delivers one 0.3 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL. Each 0.3 mL also contains 1.8 mg sodium chloride and 0.5 mg sodium metabisulfite.

Discard unit after use. The Trainer contains no medicine and no needle. Read enclosed Patient Information Leaflet carefully before using.

Usual dosage: See insert. Replace if medicine is discolored. Store at 68º to 77ºF (20º to 25ºC).

Do not refrigerate or freeze. Protect from heat and light. EpiPen ® and EpiPen Jr ® are registered trademarks of Mylan Inc., a Viatris Company.

Mfd. for Mylan Specialty L.P., Morgantown, WV 26505, USA by Meridian Medical Technologies, LLC St. Louis, MO 63146, USA Copyright © 2022 Meridian Medical Technologies. All rights reserved.

0002182 MS:50002:2C:R7 Where to inject/How to hold 0.3 mg Carton Label How to give 0.3 mg Carton Label After injection 0.3 mg Carton Label EPIPEN 2-PAK 0.3 mg Carton Label

PRINCIPAL DISPLAY PANEL – 0.15 mg EPIPEN Jr 2-PAK ® (epinephrine injection, USP) Single-Dose Auto-Injector 0.15 mg For Allergic Emergencies (Anaphylaxis) NDC 49502-501-02 This carton contains: Two EpiPen Jr ® in protective cases Patient Information Leaflet & Trainer Instructions for Use One gray Trainer The EpiPen Jr auto-injector and Trainer are not toys and should be used under adult supervision. Never put thumb, fingers or hand over orange needle end. Do not remove blue safety top until ready to use.

EpiPen Jr 2-Pak ® contains 2 EpiPen Jr ® auto-injectors and 1 Trainer. Each EpiPen Jr ® delivers one 0.15 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL. Each 0.3 mL also contains 1.8 mg sodium chloride and 0.5 mg sodium metabisulfite.

Discard unit after use. The Trainer contains no medicine and no needle. Read enclosed Patient Information Leaflet carefully before using.

Usual dosage: See insert. Replace if medicine is discolored. Store at 68º to 77ºF (20º to 25ºC).

Do not refrigerate or freeze. Protect from heat and light. EpiPen ® and EpiPen Jr ® are registered trademarks of Mylan Inc., a Viatris Company.

Mfd. for Mylan Specialty L.P., Morgantown, WV 26505, USA by Meridian Medical Technologies, LLC St. Louis, MO 63146, USA Copyright © 2022 Meridian Medical Technologies. All rights reserved.

0002183 MS:50102:2C:R7 Where to inject/How to hold 0.15 mg Carton Label How to give 0.15 mg Carton Label After injection 0.15 mg Carton Label EPIPEN Jr 2-PAK 0.15 mg Carton Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
766
Units reimbursed last 4 qtrs
2.1K
Gross reimbursed last 4 qtrs
$354.5K
Avg / prescription
$462.78
Avg / unit
$165.16
Latest quarter Q1 2026
124Rx
Medicaid pays / ea
$165.16
gross reimbursed
vs
NADAC / ea
$290.64
acquisition cost
=
Spread
−$125.48
-43% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
79% FFS 21% MCO
Fee-for-service · 602 Rx Managed care · 164 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 40 units · 0.7 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,404 units · 7.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 188 units · 0.5 per 100k residents CA Utah: no data reported UT Colorado: 45 units · 0.8 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 20 units · 0.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 136 units · 4.4 per 100k residents AR Tennessee: no data reported TN North Carolina: 48 units · 0.4 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 44 units · 1.0 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 46 units · 0.2 per 100k residents TX Florida: 176 units · 0.8 per 100k residents FL
Units reimbursed · per 100k residents
0.27.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 7.2 /100k
2 Arkansas 4.4 /100k
3 Louisiana 1.0 /100k
4 Florida 0.8 /100k
5 Colorado 0.8 /100k
6 Minnesota 0.7 /100k
7 California 0.5 /100k
8 North Carolina 0.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 syringe this page49502-0501-02 766 Rx · $354,490
1 syringe49502-0501-92 No Medicaid data
Drug total (last 4 qtrs): 766 Rx · 2,146 units · $354,490 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epinephrine (matched by generic name) — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epinephrine. CMS lists 6 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$29.01M
Claims incl. refills
120.5K
Beneficiaries
110.8K
Spend / beneficiary
$261.75
Spend / claim
$240.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for EPIPEN JR (this brand).

Top reported reactions

Headache3,072
Sinusitis2,937
Fatigue2,811
Pain2,525
Covid-192,432
Dyspnoea2,298
Nausea2,235

Reporter sex

0 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Disabling390
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,794 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 49502-0500-02 · Viatris 49502-0605-05 · Viatris →
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.