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epinephrine .3 mg/.3mL Injection, 1 syringe — NDC 00115-1694-30 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 0115-1694-30 (Billing 00115-1694-30)

by Amneal Pharmaceuticals of New York LLC · 1 CASE in 1 CARTON / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of epinephrine .3 mg/.3mL Injection from Amneal Pharmaceuticals of New York LLC, marketed since Apr 2010 and currently FDA-listed; retail pharmacies pay about $112.00 per syringe (NADAC).

NDC 00115-1694-30
🏷️ FDA NDC (as labeled) 0115-1694-30 billing pads the labeler segment with a zero
This package
Contains1 syringe Cost per ea$112.00 NADAC Per package$112.00 / 1 syringe Pack sizes2 compare ↓
Also priced by: Part D plans $128.60/unit — full pricing hub ↓
Product page 00115-1694-49 Also comes in: 1 syringe 0115-1694-49
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 0115-1694-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0115 labeler · 1694 product · 30 package
Package marketed since
Apr 1, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC)
0301151694491, 0301151695498
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) 0115-1694-30
Product NDC 0115-1694
11-digit billing NDC 00115169430
NCPDP billing unit EA — each (per item)
RxCUI 1870225, 1870230
UNII YKH834O4BH
UPC 0301151694491, 0301151695498
Application # NDA020800
SPL Set ID e13f05f1-7d21-49bb-b8d5-24bf9301c3d7
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 AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-04-01
Route SUBCUTANEOUS
Dosage form INJECTION
Substance EPINEPHRINE
TE code (Orange Book) BX · RLD · RS

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

GPI-14 3890004000D540
GPI class EPINEPHrine
GCN Seq No 016879
GCN 19862
HICL code 002050
Ingredient (HICL) Epinephrine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5F
Therapeutic class — specific (HIC3) Anaphylaxis Therapy Agents
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name EPINEPHRINE 0.3 MG AUTO-INJECT
FDB brand name Epinephrine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016879
  • GCN: 19862
  • GPI-14 (Medi-Span): 3890004000D540
  • HICL (First Databank): 002050
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 1870225
Why two NDCs? The FDA registers this code as 0115-1694-30 — a 4-4-2 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 labeler segment → 00115-1694-30. 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 EPINEPHRINE 0.3 MG AUTO-INJECT 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 $111.998 $112.00 / 1 syringe
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 $128.60 $128.60 / 1 syringe
NADAC price history (per ea) — tap or hover for the price & month
Jun 2022 Dec 2023 Mar 2026 Sep 2026 $129.603 $109.662
▼ Down 7% over the last 19 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
00115-1694-30 You're viewing this 1 CASE in 1 CARTON / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS $112.00 / ea $112.00 2010-04-01 — Active
00115-1694-49 0115-1694-49 Main listing 2 CASE in 1 CARTON / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS $112.00 / ea $224.00 2010-04-01 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($112.00 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 syringe — 1 case in 1 carton / 1 syringe, glass in 1 case / .3 ml in 1 syringe, glass.
What NDC number is used to bill for this package of epinephrine .3 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 .3 mg/.3mLthis 00115-1694-30 Amneal 1 syringe $111.998 BX Availability likely —
epinephrine .3 mg/.3mL 50090-3155-00 A-S 1 ml — BX FDA listed —
Epinephrine .3 mg/.3mL 51662-1223-01 HF 1 syringe — BX FDA listed —
Epinephrine 0.3 Adults .3 mg/.3mL 70385-2022-01 Sina 1 syringe — BX FDA listed —
epinephrine .3 mg/.3mL 70518-2048-00 REMEDYREPACK 1 syringe — BX FDA listed —
epinephrine .3 mg/.3mL 76420-0467-02 ASCLEMED 1 syringe — BX FDA listed —
epinephrine .3 mg/.3mL 76420-0834-01 Asclemed 1 syringe — BX FDA listed —
Epinephrine .3 mg/.3mL 80425-0264-01 Advanced 1 syringe — BX FDA listed —
epinephrine .3 mg/.3mL 85766-0061-01 Sportpharm 1 syringe — BX FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
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

🏛️
2010
On the market since
Apr 2010
📍
2026
Currently FDA-listed
16 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 HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • 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 TZX5469Z6I
    Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals of New York LLC
Application holderIMPAX LABORATORIES LLC
FDA applicationNDA020800 (NDA AUTHORIZED GENERIC)
Labeler code00115
First marketedApr 2010
Product typeHuman Prescription Drug
Portfolio228 products on file

More NDCs from Amneal Pharmaceuticals of New York LLC labeler code 00115

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 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 65 words ▾

1 INDICATIONS AND USAGE Epinephrine Injection is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients who weigh 15 kg or greater. Epinephrine Injection is a alpha and beta-adrenergic receptor agonist, indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of Epinephrine Injection is based on weight. (2.1) Administer Epinephrine Injection intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. (2.2) Recommended Dosage Patient’s Weight Dosage 30 kg or greater 0.3 mg 15 kg to less than 30 kg 0.15 mg In the absence of clinical improvement or if symptoms worsen after the initial treatment, a second dose of Epinephrine Injection may be administered with a second auto-injector starting 5 minutes after the first dose.

(2.1) Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. (2.1) It is recommended that patients are prescribed and have immediate access to two Epinephrine Injection devices at all times. (2.1) See full prescribing information for administration instructions.

(2.2)

2.1Recommended Dosage Recommended dosage for patients who weigh 15 kg or greater is based on weight and the dosage is provided in Table 1. Administer Epinephrine Injection intramuscularly or subcutaneously into the anterolateral aspect of the thigh. Table 1 Recommended Dosage of Epinephrine Injection Based on Patient’s Weight Patient’s Weight Dosage 30 kg or greater 0.3 mg 15 kg to less than 30 kg 0.15 mg Since the doses of epinephrine delivered from Epinephrine Injection are fixed, use other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

In the absence of clinical improvement or if symptoms worsen after the initial treatment, a second dose of Epinephrine Injection may be administered with a second auto-injector starting 5 minutes after the first dose. Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. It is recommended that patients are prescribed and have immediate access to two Epinephrine Injection devices at all times.

2.2Administration Instructions Injection: 0.3 mg (0.3 mg/0.3 mL) of clear and colorless solution in single-dose pre-filled auto-injector 0.15 mg (0.15 mg/0.15 mL) of clear and colorless solution in single-dose pre-filled auto-injector

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 0.3 mg (0.3 mg/0.3 mL) of clear and colorless solution in single-dose pre-filled auto-injector Injection: 0.15 mg (0.15 mg/0.15 mL) of 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) 0.15 mg (0.15 mg/0.15 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 Do not inject intravenously, into buttock, or into digits, hands, or feet. (5.1) Hold the child’s leg firmly in place and limit movement prior to and during injection when administering to young children or infants to minimize the risk of injection-related injury. (5.1) 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. (5.2) Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. (5.3) May aggravate certain coexisting conditions.

(5.3) The presence of a sulfite in this product should not deter use. (5.4)

5.1Injection-Related Complications Epinephrine Injection should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2.2) ] . Do not inject intravenously Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine for this inadvertent administration.

Do not inject into buttock Injection into the buttock may not provide effective treatment of anaphylaxis. If Epinephrine Injection is injected into the buttock, advise the patient to administer a second dose of Epinephrine Injection into the anterolateral aspect of the thigh if symptoms worsen or persist, and then go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with the development of Clostridial infections (gas gangrene).

Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the 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 and may not provide effective treatment of anaphylaxis. Advise the patient to administer a second dose of Epinephrine Injection into the anterolateral aspect of the thigh if experiencing anaphylaxis, and then go immediately to the nearest emergency room and 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 To minimize the risk of injection related injury when administering Epinephrine Injection to young children or infants, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

5.2Serious 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 Epinephrine Injection into the buttock [see Warnings and Precautions (5.1) ] . 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.

5.3Risks Associated with Use of Epinephrine in Certain Coexisting Conditions Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening si… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Injection-Related Complications [see Warnings and Precautions (5.1) ] Serious Infections at the Injections [see Warnings and Precautions (5.2) ] Risks Associated with Use of Epinephrine in Certain Coexisting Conditions [see Warnings and Precautions (5.3) ] Allergic Reactions Associated with Sulfite [see Warnings and Precautions (5.4) ] The following adverse reactions associated with the use of epinephrine were identified in observational trials, case reports, studies, or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular : angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy Gastrointestinal Disorders : nausea and vomiting Infections : Clostridial infections (gas gangrene) Metabolism and Nutrition Disorders : transient hyperglycemia, sweating Neurological: disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling, weakness, tremor, hypoesthesia, dizziness, headache Psychiatric : anxiety, apprehensiveness, restlessness Respiratory : respiratory difficulties Skin and Subcutaneous Tissue Disorders: bruising, bleeding, discoloration, erythema, necrotizing fasciitis, myonecrosis 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 192 words ▾

7 DRUG INTERACTIONS Cardiac glycosides, diuretics, or anti-arrhythmics: observe for development of cardiac arrhythmias. (7.1) Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, certain antihistamines, and catechol-O-methyl transferase inhibitors: may potentiate effects of epinephrine. (7.2) Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of epinephrine.

(7.3) Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of epinephrine. (7.3) Ergot alkaloids: may reverse the pressor effects of epinephrine. (7.3)

7.1Drugs Increasing Risk of Cardiac Arrhythmias 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 (5.3) and Adverse Reactions (6) ] .

7.2Drugs Potentiating Effects of Epinephrine The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine, and catechol-O-methyl transferase (COMT) inhibitors such as entacapone.

7.3Drugs Antagonizing Effects of Epinephrine 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 Elderly patients may be at greater risk of developing adverse reactions. (5.3 , 8.5)

8.1Pregnancy Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with anaphylaxis, and treatment with epinephrine should not be delayed (see Clinical Considerations) . In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant 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 (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Treatment of anaphylaxis during pregnancy should not be delayed. 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 the breastfed infants, or the effects on milk production. However, due to its poor oral bioavailability and short half-life, transfer of epinephrine into breastmilk is expected to be low. Treatment of anaphylaxis in breastfeeding patients should not be delayed.

8.4Pediatric Use The safety and effectiveness of Epinephrine Injection for the emergency treatment of type I allergic reactions, including anaphylaxis have been established in pediatric patients who weigh 15 kg or greater. The use of Epinephrine Injection for this indication is supported by clinical experience. Clinical experience with the use of epinephrine suggests that the adverse reactions seen in pediatric patients are similar in nature and extent to those both expected and reported in adults.

Since the doses of epinephrine delivered from Epinephrine Injection are fixed, use other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. The safety and effectiveness of Epinephrine Injection have not been established in pediatric patients who weigh less than 15 kg.

8.5Geriatric Use Clinical studies… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with anaphylaxis, and treatment with epinephrine should not be delayed (see Clinical Considerations) . In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant 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 (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Treatment of anaphylaxis during pregnancy should not be delayed. 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 122 words ▾

8.4Pediatric Use The safety and effectiveness of Epinephrine Injection for the emergency treatment of type I allergic reactions, including anaphylaxis have been established in pediatric patients who weigh 15 kg or greater. The use of Epinephrine Injection for this indication is supported by clinical experience. Clinical experience with the use of epinephrine suggests that the adverse reactions seen in pediatric patients are similar in nature and extent to those both expected and reported in adults.

Since the doses of epinephrine delivered from Epinephrine Injection are fixed, use other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. The safety and effectiveness of Epinephrine Injection have not been established in pediatric patients who weigh less than 15 kg.

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use Clinical studies of Epinephrine Injection for emergency treatment of type I allergic reactions, including anaphylaxis, were not conducted in geriatric patients aged 65 and over to determine whether they respond differently from younger adult patients. 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, these patients may be at greater risk for developing adverse reactions after epinephrine administration.

🆘 Overdosage 183 words ▾

10 OVERDOSAGE Overdosage of epinephrine has been reported to 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. Epinephrine overdosage can also cause transient bradycardia followed by tachycardia which may be accompanied by fatal cardiac arrhythmias; premature ventricular contractions followed by multifocal ventricular tachycardia; atrial tachycardia and occasionally by atrioventricular block; extreme pallor and coldness of the skin; metabolic acidosis; kidney failure.

Epinephrine is rapidly inactivated in the body and treatment following overdosage with epinephrine is primarily supportive. Treatment of epinephrine associated pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support. Treatment of epinephrine associated arrhythmias consists of administration of a beta-adrenergic blocking drug (such as propranolol).

If necessary, pressor effects may be counteracted by rapidly acting vasodilators or α-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology 119 words ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

🧬 Mechanism of Action 99 words ▾

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

📦 How Supplied / Storage and Handling 179 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Epinephrine Injection is a clear and colorless solution for intramuscular or subcutaneous use. Epinephrine Injection is available as an auto-injector as described in Table 2. Table 2 Epinephrine Injection Auto-injector Package Configurations and Strengths Strength Package Configuration NDC 0.3 mg/0.3 mL Each carton contains 2 single-dose prefilled auto-injectors in individual carrier tubes NDC 0115-1694-49 Auto-injector in carrier tube NDC 0115-1694-30 0.15 mg/0.15 mL Each carton contains 2 single-dose prefilled auto-injectors in individual carrier tubes NDC 0115-1695-49 Auto-injector in carrier tube NDC 0115-1695-30 Storage and Handling Protect from light.

Epinephrine Injection is light sensitive and should be stored in the individual carrier tube provided. 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 or freeze.

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. Properly dispose of all used, unwanted, or expired Epinephrine Injection, USP.

📋 Description ~1 min read ▾

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

Epinephrine Injection, USP 0.3 mg and Epinephrine Injection, USP 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for Epinephrine Injection, USP 0.3 mg and Epinephrine Injection, USP 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.

Each 0.3 mL in Epinephrine Injection, USP 0.3 mg, contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.15 mL in Epinephrine Injection, USP 0.15 mg, contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 mg sodium bisulfite, hydrochloric acid and sodium hydroxide 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 Epinephrine Injection, USP if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Administration Each Epinephrine Injection contains a single dose of epinephrine for single use. Instruct patients and/or caregivers to inspect the epinephrine solution visually through the viewing window periodically.

Epinephrine Injection should be replaced if the epinephrine solution appears discolored, cloudy, or contains particles. Instruct patients and/or caregivers on proper intramuscular or subcutaneous injection technique using the Epinephrine Injection Trainer. A Trainer device is not provided with epinephrine injection.

Patients and/or caregivers may obtain a Trainer device at www.epinephrineautoinject.com . Instructions for use of the Trainer device are provided on the Trainer label. Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of epinephrine injection in an allergic emergency.

The Trainer device may be used multiple times. For additional video instructions on the use of epinephrine injection,go to www.epinephrineautoinject.com. Instruct caregivers to hold the leg of young children or infants firmly in place and limit movement prior to and during injection. [see Warnings and Precautions (5.2) ] .

Instruct patients and/or caregivers in the appropriate use of Epinephrine Injection . Epinephrine Injection should be injected into the middle of the outer thigh (through clothing if necessary). Instruct patients and/or caregivers when a second dose of Epinephrine Injection is needed.

Administer a new Epinephrine Injection into the middle of the outer thigh starting 5 minutes after the first dose. Advise patients and/or caregivers when to seek emergency medical care for close monitoring of the type I allergic emergency and in the event that further treatment is required. Injection-Related Complications Advise patients to seek immediate medical care in the case of accidental injection into the digits, hands or feet because such an accidental injection to these areas may cause loss of blood flow to the affected area [see Warnings and Precautions (5.1) ] .

Serious Infections at the Injection Site Advise patients that 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 injection of epinephrine for anaphylaxis. Instruct 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 (5.2) ] . Risks Associated with Certain Coexisting Conditions Advise patients with coexisting conditions (cardiac arrhythmia and ischemia, coronary artery disease, hypertension, pulmonary edema, hyperthyroidism, renal impairment, Parkinson's disease, diabetes), for increased risks that may be associated with use of epinephrine [see Warnings and Precautions (5.3) ].

Storage and Handling Epinephrine Injection is light sensitive and should be stored in the individual carrier tube provided to protect it from light. The individual carrier tube is not waterproof. Instruct patients that Epinephrine Injection must be properly disposed of once the blue end caps have been removed or after use [see How Supplied/Storage and Handling (16) ] .

Manufactured for and Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 © 2025 Amneal Pharmaceuticals LLC. All rights reserved. For inquiries call 1-877-835-5472 1871-05 Rev.

03-2026-05

🧬 Pharmacodynamics 17 words ▾

12.2Pharmacodynamics When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

🧪 Nonclinical Toxicology 136 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 133 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 PATIENT INFORMATION EPINEPHRINE injection (ep″ i nef′ rin), for intramuscular or subcutaneous use Epinephrine Injection USP, 0.3 mg Each Epinephrine Injection USP, 0.3 mg delivers a single dose of 0.3 mg epinephrine USP, in 0.3 mL (0.3 mg/0.3 mL) Epinephrine Injection USP, 0.15 mg Each Epinephrine Injection USP, 0.15 mg delivers a single dose of 0.15 mg epinephrine USP, in 0.15 mL (0.15 mg/0.15 mL) For allergic emergencies (anaphylaxis) Read this Patient Information leaflet carefully before you use Epinephrine Injection and each time you get a refill.

There may be new information. You, your parent, caregiver, or others who may be able to administer Epinephrine Injection 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 Epinephrine Injection? 1. Epinephrine Injection 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. Allergic emergencies may be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

Symptoms of anaphylaxis may include: trouble breathing wheezing hoarseness (changes in the way your voicesounds) 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. It is recommended that people are prescribed and have immediate access to 2 Epinephrine Injection devices at all times.

Sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking emergency medical help. You should also have immediate access to 2 Epinephrine Injection devices in case the first device is activated before the dose can be given. A device that has been activated accidentally cannot be used to treat an allergic emergency (anaphylaxis).

Note: Epinephrine Injection has been activated if you see the needle sticking out of the red needle end and the viewing window is blocked. You may not know when an allergic emergency (anaphylaxis) will happen. Talk to your healthcare provider if you need additional Epinephrine Injection devices to keep at work, school, or other locations.

If you use 1 Epinephrine Injection device to treat an emergency allergic reaction, be sure to replace it so you always have immediate access to 2 devices. Tell your family members, caregivers, and others where you keep your Epinephrine Injection. Make sure they know 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 Epinephrine Injection right away.

Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed, after using Epinephrine Injection. Before you receive Epinephrine Injection, your healthcare provider should talk to you about when to get emergency help . If symptoms do not improve or if they worsen after the first dose, or you accidentally inject Epinephrine Injection intothe fingers, toes, hands or feet, a second dose of Epinephrine Injection may be administered with a second auto-injector starting 5 minutes after the first dose.

If more than 2 doses are needed for an allergic emergency, they must be given by a healthcare provider. What is Epinephrine Injection? Epinephrine Injection is a medicine used to treat life-threatening allergic emergencies (anaphylaxis).

It is delivered using a disposable, prefilled automatic injection device (auto-injector). Each auto-injector contains a single dose of epinephrine. Epinephr… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use EPINEPHRINE injection (ep″ i nef′ rin), for intramuscular or subcutaneous use Epinephrine Injection USP, 0.3 mg Each Epinephrine Injection USP, 0.3 mg delivers a single dose of 0.3 mg epinephrine USP in 0.3 mL (0.3 mg/0.3 mL) Epinephrine Injection USP, 0.15 mg Each Epinephrine Injection USP, 0.15 mg delivers a single dose of 0.15 mg epinephrine USP in 0.15 mL (0.15 mg/0.15 mL) For allergic emergencies (anaphylaxis) This Instructions for Use contains information on how to properly administer Epinephrine Injection.

Your Epinephrine Injection Figure A. Epinephrine Injection, USP 0.3 mg (yellow label) and Epinephrine Injection, USP 0.15 mg (orange label), showing the auto-injector and carrier tube components Important Information You Need to Know Before Administering Epinephrine Injection Epinephrine Injection is a single-dose auto-injector used for allergic emergencies (anaphylaxis) and should be used right away. Before you need to use your Epinephrine Injection, make sure your healthcare provider shows you the right way to use it.

Anyone who may be able to administer Epinephrine Injection should also understand how to use it. Check the expiration date on your Epinephrine Injection, as shown in Figure A . Replace it before the expiration date.

Read this Instructions for Use carefully in a non-emergency situation and make sure you understand them before using your Epinephrine Injection. If you have any questions, ask your healthcare provider. It is very important to hold Epinephrine Injection firmly in place for a full 10 seconds.

If you do not hold it in place long enough, Epinephrine Injection may not have time to deliver the full dose of medicine. Always carry 2 Epinephrine Injection devices. One dose may not be enough to treat an allergic emergency.

You may need to use a second Epinephrine Injection if symptoms continue or come back after the first dose. A second dose may be administered starting 5 minutes after the first dose while you wait for emergency medical help, or if the first Epinephrine Injection is activated before the dose can be given. Inject Epinephrine Injection into the muscle (intramuscular) or under the skin (subcutaneous) in the middle of the outer thigh (upper leg) (see Figure B).

Do not inject Epinephrine Injection into any other part of the body. If you accidentally inject Epinephrine Injection into the fingers, toes, hands or feet , administer a second dose of Epinephrine Injection into the middle of the outer thigh (upper leg). Epinephrine Injection can be administered through clothing if needed.

Figure B. Inject Epinephrine Injection into the middle of the outer thigh (upper leg) Each Epinephrine Injection is for single use only. The dose has been delivered if you see the needle sticking out of the red needle end after use.

It is normal for most of the medicine to remain in the auto-injector after the dose is injected. Do not take the Epinephrine Injection apart. Do not remove the blue needle shield cap and blue end cap until you are ready to use Epinephrine Injection.

Always point the red needle end downward (see Figure C ). Never put your thumb, fingers, or hand over the red needle end. The needle comes out of the red needle end.

Accidental injection into the fingers, hands, or feet may cause loss of blood flow to these areas. If an accidental injection happens, get emergency medical help right away. Figure C.

Correct way to hold the Epinephrine Injection with red needle end pointing down Preparing to Inject Epinephrine Injection Read the following information while preparing to inject Epinephrine Injection: Epinephrine Injection can be administered through clothing. Remove any objects or clothing that may block access to the injection site. Check Epinephrine Injection before use.

If the auto-injector appears damaged or broken, do not use it. Throw away (dispose of it) and use a new Epinephrine Injection. A separate Epinephrine Injection Trainer is available.

The Trainer is beige… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 38 words ▾

PRINCIPAL DISPLAY PANEL - 0.15 mg CARTON 0-15 carton

PRINCIPAL DISPLAY PANEL - 0.15 mg WRAP LABEL 0-15 wrap

PRINCIPAL DISPLAY PANEL - 0.3 mg CARTON 0-3 carton

PRINCIPAL DISPLAY PANEL - 0.3 mg WRAP LABEL 0-3 wrap

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

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 syringe00115-1694-49 291,416 Rx · $52,559,043
1 syringe this page00115-1694-30 No Medicaid data
Drug total (last 4 qtrs): 291,416 Rx · 644,723 units · $52,559,043 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 — 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.
← 00115-1689-74 · Amneal 00115-1695-30 · Amneal →
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.