Home › NDC Lookup › Ingredients › Epinephrine › 51662-1224-01
EPINEPHRINE .3 mg/.3mL Injection, 1 syringe — NDC 51662-1224-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EPINEPHRINE .3 mg/.3mL Injection, 1 syringe — NDC 51662-1224-1 (Billing 51662-1224-01)

by HF Acquisition Co LLC, DBA HealthFirst · 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of EPINEPHRINE .3 mg/.3mL Injection from HF Acquisition Co LLC, DBA HealthFirst, marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.

NDC 51662-1224-01
🏷️ FDA NDC (as labeled) 51662-1224-1 billing pads the package 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 51662-1224-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51662 labeler · 1224 product · 1 package
Package marketed since
Sep 15, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5166212241 9
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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1224-1
Product NDC 51662-1224
11-digit billing NDC 51662122401
RxCUI 727316, 1870207
UNII YKH834O4BH
Application # NDA019430
SPL Set ID 75e96faa-545b-52d6-e053-2991aa0a8fb8
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 2018-09-15
Route INTRAMUSCULAR
Dosage form INJECTION
Substance EPINEPHRINE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 727316
Why two NDCs? The FDA registers this code as 51662-1224-1 — 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 → 51662-1224-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

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

📗 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 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 · Q2 2026 $136.87 $136.87 / 1 syringe
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
51662-1224-01 You're viewing this Main listing 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS 2018-09-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Epinephrine .3 mg/.3mL 49502-0102-02 Viatris 1 syringe $141.276 AB Availability likely —
Epipen .3 mg/.3mL 49502-0500-02 Viatris 1 syringe $292.748 AB FDA listed —
Auvi-Q .3 mg/.3mL 60842-0023-01 kaleo, 2 doses $309.376 BX Discontinued —
Epinephrine .3 mg/.3mL 50090-4543-00 A-S 1 ml — AB FDA listed —
Epinephrine .3 mg/.3mLthis 51662-1224-01 HF 1 syringe — AB FDA listed —
Epinephrine .3 mg/.3mL 71872-7135-01 Medical 1 syringe — AB FDA listed —
Auvi-Q .3 mg/.3mL 71872-7173-01 Medical 1 dose — BX FDA listed —
Epipen .3 mg/.3mL 76420-0584-02 Asclemed 1 syringe — AB FDA listed —
Epinephrine .3 mg/.3mL 51662-1320-01 HF 3 ml — BX FDA listed —
Auvi-Q .3 mg/.3mL 71872-7329-01 Medical 1 dose — BX FDA listed —
Auvi-Q .3 mg/.3mL 85766-0277-02 Sportpharm 2 doses — BX 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderVIATRIS SPECIALTY LLC
FDA applicationNDA019430 (NDA)
Labeler code51662
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio333 products on file

More NDCs from HF Acquisition Co LLC, DBA HealthFirst labeler code 51662

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🧪 Nonclinical Toxicology 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 161 words ▾

1 INDICATIONS & 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.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE & ADMINISTRATION Selection of the appropriate dosage strength (EpiPen 0.3 mg or EpiPen Jr 0.15 mg) is determined according to patient body weight. • Patients greater than or equal to 30 kg (approximately 66 pounds or more): EpiPen 0.3 mg • Patients 15 to 30 kg (33 pounds to 66 pounds): EpiPen Jr 0.15 mg Inject EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. 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 contains a single dose of epinephrine for single-use injection. 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. The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.

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 Auto-Injector should be inspected visually for particulate matter and discoloration.

Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [see HOW SUPPLIED/STORAGE AND HANDLING (16.2)].

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS & STRENGTHS • EpiPen: Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector • EpiPen Jr: Injection, 0.15 mg/0.3 mL, epinephrine injection, USP, pre-filled auto-injector

⛔ Contraindications 3 words ▾

4 CONTRAINDICATIONS None

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS

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 & USAGE (1), DOSAGE & 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 & 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 EpiPen to young children, instruct caregivers to 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 Sulfite The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive. Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.

The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.

5.5Disease Interactions Some patients may be at greater risk for… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 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)]. 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. 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 events 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 WARNINGS AND PRECAUTIONS (5.2)]. Injection into the buttock has resulted in cases of gas gangrene [see WARNINGS AND PRECAUTIONS (5.2)].

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)].

🔄 Drug Interactions 97 words ▾

7 DRUG INTERACTIONS 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)]. The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.

The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine. Ergot alkaloids may also reverse the pressor effects of epinephrine.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

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/m2 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/m2 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/m2 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/m2 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/m2 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 & ADMINISTRATION (2)]. 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 subjects. However, other reported clinical experience with use of epinephrine for the treatment of an… [Excerpted — this section continues on DailyMed.]

🆘 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.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE & HANDLING EPIPEN® (EPINEPHRINE INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1224-1 EPIPEN® (EPINEPHRINE INJECTION, USP) AUTO INJECTOR 0.30mg NDC 51662-1225-1 EPIPEN JR® (EPINEPHRINE INJECTION, USP) AUTO INJECTOR 0.15mg HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms

16.1How Supplied EpiPen Auto-Injectors (epinephrine injections, USP 0.3 mg/0.3 mL) are available as EpiPen 2-Pak®, NDC 49502-500-02, a pack that contains two EpiPen Auto-Injectors (epinephrine injections, USP 0.3 mg/0.3 mL) and one EpiPen Auto-Injector trainer device. EpiPen Jr Auto-Injectors (epinephrine injections, USP 0.15 mg/0.3 mL) are available as EpiPen Jr 2-Pak®, NDC 49502-501-02, a pack that contains two EpiPen Jr Auto-Injectors (epinephrine injections, USP 0.15 mg/0.3 mL) and one EpiPen Auto-Injector trainer device.

EpiPen 2-Pak® and EpiPen Jr 2-Pak® also include an S-clip to clip two carrier tubes together. Rx only

16.2Storage 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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° 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 particles.

📋 Description ~1 min read ▾

11 DESCRIPTION EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are 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.

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. 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)]. STRUCTURE

🧪 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 under the conditions noted under INDICATIONS & 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.

📖 Instructions for Use ~3 min read ▾

PATIENT INFORMATION/INSTRUCTIONS FOR USE EPIPEN® (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® (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. You, your parent, caregiver, or others who may be in a position to administer 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 the EpiPen and EpiPen Jr? 1.

EpiPen and EpiPen Jr contain epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening, can happen within minutes, and 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) 2.

Always carry your EpiPen or EpiPen Jr with you because you may not know when anaphylaxis may happen. Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your EpiPen or EpiPen Jr and how to use it before you need it.

You may be unable to speak in an allergic emergency. 3. When you have an allergic emergency (anaphylaxis) • Use the EpiPen or EpiPen Jr right away. • Get emergency medical help right away.

You may need further medical attention. You may need to use a second EpiPen or EpiPen Jr if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.

What are EpiPen and EpiPen Jr? • EpiPen and EpiPen Jr are disposable, prefilled automatic injection devices (auto-injectors) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine. • EpiPen and EpiPen Jr are for immediate self (or caregiver) administration and do not take the place of emergency medical care. You should get emergency help right away after using EpiPen and EpiPen Jr. • EpiPen and EpiPen Jr are for people who have been prescribed this medicine by their healthcare provider. • The EpiPen Auto-Injector (0.3 mg) is for patients who weigh 66 pounds or more (30 kilograms or more). • The EpiPen Jr Auto-Injector (0.15 mg) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms). • It is not known if EpiPen and EpiPen Jr are safe and effective in children who weigh less than 33 pounds (15 kilograms).

What should I tell my healthcare provider before using the EpiPen or EpiPen Jr? Before you use EpiPen or EpiPen Jr, tell your healthcare provider about all your medical conditions, but especially if you: • have heart problems or high blood pressure • have diabetes • have thyroid problems • have asthma • have a history of depression • have Parkinson’s disease • have any other medical conditions • are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby. • are breastfeeding or plan to breastfeed.

It is not kn… [Excerpted — this section continues on DailyMed.]

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

PRINCIPAL DISPLAY PANEL, YELLOW PEN 0.3mg Rx only For Allergic Emergencies (Anaphylaxis) (epinephrine injection, USP) Auto-Injectors 0.3 mg Never put thumb, fingers or hand over orange tip. Do not remove blue safety release until ready to use. Each EpiPen®Auto-Injector delivers one 0.3 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.3 mg/0.3mL.

Discard unit after use. The Trainer contains no medicine and no needle. Read enclosed patient package insert carefully before using.

See enclosed Patient Information Leaflet for complete instructions for use. Note: The needle comes out of the orange tip. Never put your thumb, fingers or hand over the orange tip.

Register your EpiPen® Auto-Injectors at www.epipen.com to receive free refill reminders Replace if discolored. Store at 68º to 77ºF (20º to 25ºC). Do not refrigerate.

Protect from light. Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, USA by Meridian Medical Technologies, Inc., Columbia, MD 21046, USA, a Pfizer company EpiPen® and EpiPen Jr® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L.P. of Morgantown, WV 26505, USA Copyright © 2017 Meridian Medical Technologies. All rights reserved.

MS:50002:2C:R3 YELLOW LEAFLET

PRINCIPAL DISPLAY PANEL, SERIALIZED LABEL 0.3mg SERIALIZED LABEL

PRINCIPAL DISPLAY PANEL, GREEN 0.15mg Rx only For Allergic Emergencies (Anaphylaxis) (epinephrine injection, USP) Auto-Injectors 0.15 mg Never put thumb, fingers or hand over orange tip. Do not remove blue safety release until ready to use. Each EpiPen Jr®Auto-Injector delivers one 0.15 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL.

Discard unit after use. The Trainer contains no medicine and no needle. Read enclosed patient package insert carefully before using.

See enclosed Patient Information Leaflet for complete instructions for use. Note: The needle comes out of the orange tip. Never put your thumb, fingers or hand over the orange tip.

Register your EpiPen Jr® Auto-Injectors at www.epipen.com to receive free refill reminders Replace if discolored. Store at 68º to 77ºF (20º to 25ºC). Do not refrigerate.

Protect from light. Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, USA by Meridian Medical Technologies, Inc., Columbia, MD 21046, USA, a Pfizer company EpiPen® and EpiPen Jr® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L.P. of Morgantown, WV 26505, USA Copyright © 2017 Meridian Medical Technologies. All rights reserved.

MS:50102:2C:R3 GREEN Leaflet 2

PRINCIPAL DISPLAY PANEL, 0.15mg SERIALIZED LABEL SERIALIZED .015

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

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

Medicare Part D (outpatient prescription) spending for Epinephrine — 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. 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.

About this NDC listing & data coverage

Finished prescription product
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 — 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 HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst 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.
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.
← 51662-1223-01 · HF 51662-1225-01 · HF →
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.