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Atropine

Atropine is an anticholinergic (antimuscarinic) medicine used as an injection for emergencies like poisoning, slow heart rhythms and cardiac arrest, for surgery-related secretions and gut spasms, and as eye drops or ointment to dilate the pupil and relax eye focusing.

Brand names Isopto AtropineATROPEN Auto-Injector
Drug classes Anticholinergic
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 50 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Other forms & routes:
Ophthalmic
Atropine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Atropine is a fast-acting anticholinergic medicine that blocks acetylcholine at muscarinic receptors (the body's “rest and digest” signals), a long-familiar standby given by injection in emergencies and around surgery and used as eye drops or ointment to widen the pupil and relax eye focusing; it has been on the U.S. market since about 1971 and is available generically. Short-term use is usually well tolerated, though most people notice dry mouth, blurred vision, light sensitivity, a faster heartbeat or flushing. Watch for overheating, since atropine cuts down sweating, and get help for fever, no sweating in the heat, or confusion. Tell your care team first about heart disease, glaucoma, bladder trouble or chronic lung disease.

Clinical pearls

  • Atropine eye drops can leave the pupil wide and near vision blurry for days, so carry sunglasses and wait to drive.
  • After each drop, press the inner corner of the eye so less atropine reaches the bloodstream, especially in children.
  • The ATROPEN goes into the outer thigh muscle, and emergency medical care is still needed right away after using it.
  • After an atropine injection, pumping and discarding breast milk for 24 hours is suggested if you are breastfeeding.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection, Eye drops, Eye ointment
Earliest FDA record1960
Companies listing it with the FDA26
FDA label last updatedSep 15, 2022
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Atropine, written from its FDA label.

What Atropine is used for

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Atropine is used in several forms, and each product has its own approved uses.

  • Atropine Sulfate injection: temporary blockade of severe or life-threatening muscarinic effects, including reducing secretions (antisialagogue) and blocking vagal effects on the heart (antivagal).
  • Atropine Sulfate injection: antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, depending on the label.
  • Atropine Sulfate injection: bradyasystolic cardiac arrest or symptomatic bradycardia, depending on the label.
  • Some older injection labels: pre-anesthetic use to reduce salivation and bronchial secretions, gut spasms (pylorospasm), ureteral and biliary colic (with morphine), and relaxing the gut during hypotonic radiography.
  • ATROPEN Auto-Injector (intramuscular): poisoning by organophosphorus nerve agents and by organophosphorus or carbamate insecticides, in adults and children.
  • Atropine sulfate eye drops and Isopto Atropine: mydriasis, cycloplegia, and penalization of the healthy eye in amblyopia.
  • Atropine Sulfate eye ointment: mydriasis and/or cycloplegia, cycloplegic refraction, and pupil dilation in inflammatory conditions of the iris and uveal tract.

How Atropine works

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Atropine is an antimuscarinic. It blocks acetylcholine, a natural messenger, from acting on muscarinic receptors in glands, smooth muscle and the heart. This reduces secretions, relaxes smooth muscle, and can raise a slow heart rate.

The block is competitive, so it can be overcome when acetylcholine levels rise.

Atropine dosage

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Dosing depends on the product and the reason for use. Do not mix up regimens between products.

  • Injection: usually given by a healthcare professional, most often into a vein, with the dose adjusted to heart rate, blood pressure and symptoms.
  • ATROPEN Auto-Injector: a single-dose device injected into the outer thigh muscle. Three injections may be needed for severe symptoms, and emergency medical care should be sought immediately.
  • Eye drops and ointment: applied in the eye as directed by your prescriber.

Follow your prescriber's instructions and the product label.

Dosing details from the FDA-approved label

From the Atropine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • ATROPEN Auto-Injector: mild symptoms (two or more mild symptoms of nerve agent or insecticide exposure)
    • First dose: one (1) ATROPEN injection intramuscularly into the mid-lateral (outer) thigh
    • If at any time after the first injection the patient has any of the severe symptoms, administer two (2) additional ATROPEN injections in rapid succession
    • Wait 10 to 15 minutes for ATROPEN to take effect
    • If no severe symptoms develop after 10 to 15 minutes, no addition
    • Strength by weight: over 41 kg (90 pounds) 2 mg; 18 kg to 41 kg 1 mg; 7 kg to 18 kg 0.5 mg; less than 7 kg 0.25 mg
  • ATROPEN Auto-Injector: severe symptoms (unconscious or any severe symptom)
    • Immediately administer three (3) ATROPEN injections intramuscularly into the patient's mid-lateral thigh in rapid succession
    • Strength by weight: over 41 kg (90 pounds) 2 mg; 18 kg to 41 kg 1 mg; 7 kg to 18 kg 0.5 mg; less than 7 kg 0.25 mg
  • Atropine Sulfate injection, adults: antisialagogue or other antivagal (preanesthesia and preoperatively during surgery)
    • 0.5 to 1 mg IV/IM/SC 30 to 60 minutes preoperatively
    • Repeat as needed every 4 to 6 hours
    • Maximum: Maximum total dose 3 mg
    • Patients with ischemic heart disease: do not exceed 0.04 mg/kg
  • Atropine Sulfate injection, adults: organophosphorus, carbamate, or muscarinic mushroom poisoning
    • 1 to 6 mg IV/IM/ET depending on severity of symptoms
    • Repeat as needed every 3 to 5 minutes
    • Dose may be doubled with each administration until response
    • Maintenance: 10% to 20% of the loading dose required for response as a continuous infusion per hour, and titrate
    • Maximum: No maximum total dose
    • Patients with ischemic heart disease: do not exceed 0.04 mg/kg
  • Atropine Sulfate injection, adults: symptomatic bradycardia
    • 0.5 mg IV/IM or 1 to 2 mg ET diluted in no more than 10 mL sterile water for injection or 0.9% sodium chloride
    • As needed every 3 to 5 minutes
    • Maximum: Maximum total dose 3 mg
    • Do not rely on atropine in type II second-degree or third-degree AV block with wide QRS complexes; no effect in transplanted hearts
  • Atropine Sulfate injection, pediatric: antisialagogue or other antivagal (preanesthesia and during surgery)
    • 0.02 mg/kg IV/IM/SC 30 to 60 minutes preoperatively
    • Repeat as needed every 4 to 6 hours
    • Maximum: Single dose: less than 12 years old 0.5 mg, 12 years and older 1 mg. Total dose: less than 12 years old 1 mg, 12 years and older 2 mg
    • Weight-based dosing
  • Atropine Sulfate injection, pediatric: organophosphorus, carbamate or muscarinic mushroom poisoning
    • 0.02 to 0.06 mg/kg IV/IM/IO/ET
    • Repeat as needed every 5 minutes
    • Dose may be doubled with each administration until response
    • Weight-based dosing
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION ATROPEN is a single-dose autoinjector intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings; definitive medical care should be sought immediately. ( 2.1 ) Dosage is dependent on weight. ( 2.2 ) Dosage for Mild Symptoms: If the patient experiences two or more mild symptoms, administer one injection intramuscularly into the mid-lateral thigh. If, at any time after the first dose, the patient develops any of the severe symptoms, administer two additional injections intramuscularly in rapid succession. ( 2.2 ) Dosage for Severe Symptoms: If the patient is either unconscious or has any of the severe symptoms, immediately administer three injections intramuscularly into the patient's mid-lateral thigh in rapid succession. ( 2.2 ) 2.1 Important Administration Information It is recommended that three ATROPEN autoinjectors be available for use in each patient at risk for organophosphorus or carbamate poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration ( 2.2 )] . Different dose strengths of ATROPEN are available depending on the patient's weight. ATROPEN should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication, but may be administered by a caregiver or self-administration if a trained provider is not available. Only administer ATROPEN to patients experiencing symptoms of organophosphorus or carbamate poisoning in a situation where exposure is known or suspected. ATROPEN is a single-dose autoinjector intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately. ATROPEN should be administered as soon as symptoms of organophosphorus or carbamate poisoning appear. In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant (preferably a benzodiazepine) if seizure is suspected in the unconscious individual since the classic tonic-clonic jerking may not be apparent due to the effects of the poison. A cholinesterase reactivator such as pralidoxime may serve as an important adjunct to atropine therapy. Close supervision of all treated patients is indicated for at least 48 to 72 hours.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Atropine side effects

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Most side effects come from atropine's drying and speeding-up effects.

Common side effects

  • Dry mouth
  • Blurred vision
  • Dry eyes and sensitivity to light
  • Fast heartbeat or palpitations
  • Flushing
  • Dizziness and headache
  • Constipation
  • Trouble urinating
  • Constipation, nausea, vomiting, abdominal pain
  • Pain at the injection site

When to get medical help

  • Get emergency help for signs of an allergic reaction, such as a spreading rash, swelling, or trouble breathing.
  • Seek help for a very fast or irregular heartbeat, or chest pain.
  • Seek help for overheating, high fever, or lack of sweating in hot weather or with exercise.
  • Call right away for confusion, hallucinations, or delirium.
  • Seek care for eye pain or sudden vision changes, which could signal acute glaucoma.
  • Get help if you cannot urinate or have worsening stomach symptoms.

Atropine warnings and precautions

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  • Heart effects: atropine can cause fast or irregular heartbeats and may worsen ischemia (poor blood flow to the heart) in people with a recent heart attack or severe coronary artery disease.
  • Heat injury: reduced sweating can cause overheating, so avoid heavy exercise and heat.
  • Acute glaucoma: it may be triggered in susceptible people.
  • Urinary retention: risk is higher with bladder outflow obstruction.
  • Pyloric stenosis: it may cause a complete blockage.
  • Chronic lung disease: it can thicken airway secretions and form dangerous plugs.
  • Allergic reactions: these include anaphylaxis.

Atropine interactions

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Two interactions are highlighted.

  • Pralidoxime: atropine effects such as flushing, dilated pupils, fast heartbeat and dryness may appear earlier than expected, because pralidoxime can boost atropine's effect.
  • Barbiturates: atropine may increase their effect, so they should be used cautiously for convulsions.

Interactions listed in the FDA-approved label

From the Atropine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Pralidoxime: Signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than expected when atropine is used alone, because pralidoxime may potentiate the effect of atropine. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases, though similar behavior has occurred in organophosphate poisoning not treated with pralidoxime.
  • Barbiturates: Barbiturates are potentiated by the anticholinesterases; atropine may potentiate the effect of barbiturates. Use barbiturates cautiously in the treatment of convulsions resulting from exposure to atropine.
Read the label’s full interactions text

7 DRUG INTERACTIONS Pralidoxime: The signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected than when atropine is used alone. ( 7.1 ) Barbiturates: Atropine may potentiate the effect of barbiturates. ( 7.2 ) 7.1 Pralidoxime When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone because pralidoxime may potentiate the effect of atropine. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime. 7.2 Barbiturates Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to atropine.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Atropine against a supplement or herb →

Before taking Atropine

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  • No contraindications are listed in one injection label.
  • Tell your care team about heart disease, rhythm problems, or a recent heart attack.
  • Mention glaucoma, bladder outflow obstruction, pyloric stenosis, or chronic lung disease.
  • Tell them about any past allergic reaction to atropine.
  • Pregnancy: data are limited, and life-sustaining treatment should not be withheld because of fetal concerns.
  • Breastfeeding: traces pass into milk, and pumping and discarding milk for 24 hours after injection may reduce infant exposure.
  • Children: nervous system effects may appear earlier and at lower doses.
  • Older adults: dosing is cautious, usually starting low.

Atropine overdose

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Too much atropine can cause flushing, dry skin and mouth, fast heartbeat, widely dilated pupils, blurred vision, and a dangerously high fever. Confusion, hallucinations, delirium and coma can occur, and severe cases can lead to breathing depression, circulatory collapse and death. Treatment is supportive and may include oxygen or breathing support, cooling measures, bladder catheterization, fluids, a darkened room, and a benzodiazepine for severe agitation or seizures.

What Atropine does in the body

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Atropine can first slow the heart slightly, then speed it up as vagal control is blocked. It can reverse slow heart rhythms caused by vagal stimulation. It also reduces secretions and sweating, dilates the pupil, and can lower blood pressure when standing. In clinical doses it does not depress the central nervous system, but large or repeated doses may depress breathing.

How your body processes Atropine

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After an intramuscular injection, atropine peaks in the blood at about 30 minutes, and exercise can increase absorption. It spreads throughout the body, and about 44% is bound to plasma proteins. The half-life is about 2 to 4 hours, and it is more than doubled in children under 2 and adults over 65. Much of it is broken down in the liver, and 13 to 50% leaves unchanged in the urine.

How to store Atropine

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Store between 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF) . Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Atropine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Atropine — the kind of thing our pharmacy team would talk through with you at the counter.

What is atropine used for?

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It depends on the form. The injection is used in emergencies like poisonings and slow heart rhythms, and around surgery to reduce secretions. The eye drops and ointment dilate the pupil and relax eye focusing. ATROPEN is specifically for nerve agent and insecticide poisoning.

How is it given?

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Injections are given by a healthcare professional, usually into a vein. ATROPEN is injected into the outer thigh in an emergency, and you should seek medical care right away. Eye products go in the eye as your prescriber directs, so follow the label.

What side effects should I expect?

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Dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing, dizziness, and constipation are common. These come from atropine's drying effects. Injection site pain can also happen.

When should I get help right away?

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Seek emergency help for trouble breathing, swelling or a spreading rash, chest pain, a racing or irregular heartbeat, hallucinations, or a high fever with no sweating. Eye pain with vision changes and being unable to urinate also need prompt attention.

Can I exercise or be out in the heat?

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Be careful. Atropine can reduce sweating, which may lead to overheating in warm weather or with heavy exercise. Avoid excessive heat and strenuous activity as much as you can.

Is it safe in pregnancy or while breastfeeding?

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Data in pregnancy are limited, but in life-threatening emergencies treatment should not be withheld. Small amounts pass into breast milk. For the injection, the label suggests pumping and discarding milk for 24 hours afterward if you wish to limit infant exposure.

Is Atropine available over the counter?

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No. Atropine is a prescription medicine: every Atropine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Atropine first available?

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The earliest FDA record we hold for Atropine is from 1960: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Atropine was first used.

Who makes Atropine?

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26 companies currently list Atropine products in the FDA's NDC Directory, including Medical Purchasing Solutions, LLC, HF Acquisition Co LLC, DBA HealthFirst, Somerset Therapeutics, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Atropine on HelloPharmacist

🌿Drug & Supplement CheckerAtropine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Atropine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Atropine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Atropine forms and strengths (how it comes)

Atropine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Atropine inactive ingredients by manufacturer.

Injection

Endotracheal · Into a muscle · Into a vein · Intramedullary · Intravascular · Under the skin
Brands ATROPEN Auto-Injector
How this form is used
What it may be used for
  • ATROPEN Auto-Injector is used for poisoning by organophosphorus nerve agents, and organophosphorus or carbamate insecticides, in adults and children.
  • Atropine Sulfate injection is used to block severe or life-threatening muscarinic effects, including as an antisialagogue, an antivagal agent, and an antidote for organophosphorus or muscarinic mushroom poisoning.
  • Some Atropine Sulfate injection labels also list bradyasystolic cardiac arrest or symptomatic bradycardia.
Important instructions
  • ATROPEN Auto-Injector is a single-dose device injected into the mid-lateral thigh muscle, and definitive medical care should be sought immediately.
  • ATROPEN dosing depends on weight and symptom severity.
  • Atropine Sulfate injection is usually given into a vein, but other routes are possible, and the dose is adjusted to heart rate, blood pressure and symptoms.
  • Atropine Sulfate injection solution should be clear and the seal intact before use.
Available strengths 8 strengths
0.05 mg/mL 0.1 mg/mL 0.25 mg/0.3 mL 0.4 mg/mL 0.5 mg/0.7 mL 1 mg/0.7 mL
Show 2 more strengths Show fewer strengths
1 mg/mL 2 mg/0.7 mL
85 FDA-listed product records ⓘ

Eye drops

In the eye
Brands Isopto Atropine
How this form is used
What it may be used for
  • Atropine sulfate eye drops are used for mydriasis, cycloplegia, and penalization of the healthy eye in amblyopia.
  • Isopto Atropine 1% is used for mydriasis, cycloplegia, and penalization of the healthy eye in amblyopia.
  • One atropine sulfate 1% eye drop label covers adults and children aged 3 months and older.
Available strengths 1 strength
10 mg/mL
38 FDA-listed product records ⓘ

Eye ointment

In the eye
How this form is used
What it may be used for
  • Atropine Sulfate eye ointment is used for mydriasis and/or cycloplegia.
  • Atropine Sulfate eye ointment is used for cycloplegic refraction and pupil dilation in inflammatory conditions of the iris and uveal tract.
Available strengths 1 strength
10 mg/g
2 FDA-listed product records ⓘ

Atropine on the U.S. market: products, makers and brands

How Atropine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

26 companies list 78 Atropine product records with the FDA, mostly as injection, eye drops, eye ointment; the earliest marketing or approval year on record is 1960. Brand names on the directory include Isopto Atropine, ATROPEN Auto-Injector; the rest are generics.

3
Dose forms ⓘ
26
Labelers (makers, repackagers, distributors)
4
Brand names
78
FDA-listed product records ⓘ
1960
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Medical Purchasing Solutions, LLC12%
HF Acquisition Co LLC, DBA HealthFirst10%
Somerset Therapeutics, LLC9%
Meridian Medical Technologies LLC6%
ProPharma Distribution6%
Henry Schein, Inc.5%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Atropine is used (Medicaid data)

A general measure of how commonly Atropine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Atropine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

111,807
Medicaid prescriptions filled (Q1–Q4 2025)
$5.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Atropine prescribed? Of the 1,601 medications we measure, Atropine ranks #494 by Medicaid prescriptions — more than 69% of them.

Where Atropine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #494 of 1,601
#489 Palonosetron Injection 116,599 Rx #490 Cefpodoxime 115,402 Rx #491 Magnesium Sulfate Hept... 113,083 Rx #492 Nystatin and Triamcino... 112,193 Rx #493 Vancomycin Injection 112,053 Rx #494 Atropine 111,807 Rx #495 Lifitegrast Ophthalmic 109,594 Rx #496 Midazolam Nasal Spray 109,459 Rx #497 Digoxin 109,371 Rx #498 Upadacitinib 108,976 Rx #499 Chlordiazepoxide 107,446 Rx

Utilization by Atropine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg/mL ophthalmic solution is the most-dispensed Atropine product — about 90% of these Medicaid prescriptions.

atropine sulfate 10 MG/ML Ophthalmic Solution Most dispensed

100,738 Medicaid prescriptions (Q1–Q4 2025) 90% of Atropine prescriptions shown $4.5M gross reimbursement (before rebates) ≈ $45 per prescription (gross)

Summed across the 18 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1190655

1 ML atropine sulfate 0.4 MG/ML Injection

7,865 Medicaid prescriptions (Q1–Q4 2025) 7% of Atropine prescriptions shown $668,426 gross reimbursement (before rebates) ≈ $85 per prescription (gross)

Summed across the 2 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666781

10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe

1,113 Medicaid prescriptions (Q1–Q4 2025) <1% of Atropine prescriptions shown $104,251 gross reimbursement (before rebates) ≈ $94 per prescription (gross)

Summed across the 3 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1190546

atropine sulfate 0.4 MG/ML Injectable Solution

1,058 Medicaid prescriptions (Q1–Q4 2025) <1% of Atropine prescriptions shown $30,389 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 3 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1190776

1 ML atropine sulfate 1 MG/ML Injection

1,033 Medicaid prescriptions (Q1–Q4 2025) <1% of Atropine prescriptions shown $38,041 gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 3 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1190795

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Atropine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 29 of 138 listed Atropine NDCs with Medicaid activity.

Compare Atropine products

A representative set of FDA-listed product records for Atropine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 78 of 78 products — FDA National Drug Code Directory. See every product, package size and price: browse all 78 Atropine NDCs →

Atropine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 5 Atropine recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jul 24, 2026 · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
  • Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN… Lots: Lot #: 24353, Exp. Date: 9/30/2026. FDA record D-0795-2026 →
Ongoing Class I Dec 21, 2023 · Pfizer Inc.
Presence of Particulate Matter; identified as glass
  • Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (cart… Lots: Lot GY2496, Exp 02/01/2025 FDA record D-0235-2024 →
Class III Dec 16, 2024 · Terminated · SOMERSET THERAPEUTICS LLC
Failed Impurities/Degradation Specifications
  • Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 Lots: Lot #: A240211, Exp. Date April 2026 FDA record D-0169-2025 →
Class II Jul 3, 2023 · Terminated · Accord Healthcare, Inc.
Presence of Particulate Matter: Particulate matter identified as fiber.
  • Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals L… Lots: Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025 FDA record D-0917-2023 →
Class II Apr 13, 2022 · Terminated · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
  • Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-1035-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Atropine RxCUI 1223 7 dose forms · 28 strengths
  2. Dose form (SCDF) Injectable Solution RxCUI 370624 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.3 MG/ML RxCUI 1190764 sulfate 0.4 MG/ML RxCUI 1190776 sulfate 0.54 MG/ML RxCUI 1145629 sulfate 0.6 MG/ML RxCUI 1190787 sulfate 1.25 MG/ML RxCUI 1190800
  4. Dose form (SCDF) Ophthalmic Ointment RxCUI 374552 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.005 MG/MG RxCUI 1190563 sulfate 0.01 MG/MG RxCUI 1190570
  5. Dose form (SCDF) Ophthalmic Solution RxCUI 370964 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.31 MG/ML RxCUI 1190766 sulfate 0.62 MG/ML RxCUI 1190790 sulfate 1 MG/ML RxCUI 1190796 sulfate 1.25 MG/ML RxCUI 1190801 sulfate 10 MG/ML RxCUI 1190655 sulfate 2.5 MG/ML RxCUI 1190806 sulfate 20 MG/ML RxCUI 1190817 sulfate 5 MG/ML RxCUI 1190668
  6. Dose form (SCDF) Oral Tablet RxCUI 370625 No current FDA listing
    Clinical drug / strength (SCD) sulfate 0.4 MG RxCUI 1190692 sulfate 0.6 MG RxCUI 1190783

Look up RxCUI 1223 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Atropine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Solution/ Drops · Ophthalmic 10 mg/mL $4.16–$11.51 per mL NDC details & price history
Solution · Ophthalmic 10 mg/mL $9.70 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Atropine brand names

Atropine is sold under 2 brand names in the FDA directory — Isopto Atropine, ATROPEN Auto-Injector. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Isopto Atropine ATROPEN Auto-Injector

Who makes Atropine: manufacturers and labelers

26 companies list Atropine products with the FDA. By number of product records, the largest are Medical Purchasing Solutions, LLC, HF Acquisition Co LLC, DBA HealthFirst, Somerset Therapeutics, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Medical Purchasing Solutions, LLC 9 HF Acquisition Co LLC, DBA HealthFirst 8 Somerset Therapeutics, LLC 7 Meridian Medical Technologies LLC 5 ProPharma Distribution 5 Henry Schein, Inc. 4 A-S Medication Solutions 3 Accord Healthcare, Inc., 3 Amneal Pharmaceuticals NY LLC 3 Gland Pharma Limited 3 Hikma Pharmaceuticals USA Inc. 3 Lifestar Pharma LLC 3 Remedyrepack Inc. 3 Alcon Laboratories, Inc. 2 American Regent, Inc. 2 Amneal Pharmaceuticals LLC 2 Bausch & Lomb Incorporated 2 Hospira, Inc. 2 Redpharm Drug 2 Apotex Corp. 1 Bausch & Lomb Americas Inc. 1 Edenbridge Pharmaceuticals LLC. 1 Fresenius Kabi USA, LLC 1 International Medication Systems, Limited 1

…and 2 more on the FDA NDC directory.

Atropine drug class (RxNorm)

Atropine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Atropine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 15, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Atropine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Atropine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
50
Finished products in the current FDA directory
78
Companies listing them (makers, repackagers, distributors)
26
FDA labeler codes behind them ⓘ
26
Linked representative label ⓘ
Meridian Medical Technologies LLC
Linked label effective
Sep 15, 2022
Composite sections available
22
Linked SPL Set ID
e2d4307d-da8f-49f5-aac0-02355dd9ffb7
Linked SPL Document ID
f1736bb6-219c-48dd-969d-f26f6fbad350
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Meridian Medical Technologies LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →