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Atropine sulfate 10 mg/mL Solution/ Drops — NDC 42799-0826-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Atropine sulfate 10 mg/mL Solution/ Drops — NDC 42799-826-02 (Billing 42799-0826-02)

by Edenbridge Pharmaceuticals LLC. · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Atropine sulfate 10 mg/mL Solution/ Drops from Edenbridge Pharmaceuticals LLC., marketed since May 2026 and currently FDA-listed; retail pharmacies pay about $5.13 per mL (NADAC).

NDC 42799-0826-02
🏷️ FDA NDC (as labeled) 42799-826-02 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle Cost per mL$5.13 NADAC Per package$25.67 / 5 ml Pack sizes3 compare ↓
Also priced by: Part D plans $7.91/unit — full pricing hub ↓
Product page 42799-0826-01 Also comes in: 2 mL 42799-826-01 15 mL 42799-826-03
Rx only Generic 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

⚠️
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0795-2026
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0235-2024
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) 42799-826-02
Product NDC 42799-826
11-digit billing NDC 42799082602
NCPDP billing unit ML — per mL (volume)
RxCUI 1190655
UNII 03J5ZE7KA5
UPC 0342799826035, 0342799826028, 0342799826011
Application # ANDA219013
SPL Set ID b39f5876-5d6f-4a8f-bd24-bd4be24ff568
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-06
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance ATROPINE SULFATE
TE code (Orange Book) AT1 · RLD · RS

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

GPI-14 86350010102010
GCN Seq No 007866
GCN 32952
HICL code 002004
Ingredient (HICL) Atropine Sulfate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6J
Therapeutic class — specific (HIC3) Mydriatics
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name ATROPINE 1% EYE DROP
FDB brand name Atropine Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007866
  • GCN: 32952
  • GPI-14 (Medi-Span): 86350010102010
  • HICL (First Databank): 002004
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1190655
Why two NDCs? The FDA registers this code as 42799-826-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42799-0826-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the 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
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 ATROPINE 1% EYE DROP Ingredient Atropine Sulfate
📗 Our plain-language guide HelloPharmacist
  • 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...
  • 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 p...
  • 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 c...
  • 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 wit...
📖 Read our full Atropine 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 mLPer package
Retail pharmacies payNADAC · weekly $5.134 $25.67 / 5 ml
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 $7.91 $39.53 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Jul 2026 Aug 2026 Sep 2026 $5.575 $5.134
▼ Down 8% over the last 3 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
42799-0826-01 42799-826-01 Main listing 1 BOTTLE in 1 CARTON / 2 mL in 1 BOTTLE $11.51 / mL $23.03 2026-05-06 — Active
42799-0826-02 You're viewing this 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE $5.13 / mL $25.67 2026-05-06 — Active
42799-0826-03 42799-826-03 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE $4.16 / mL $62.43 2026-05-06 — Active

Per mL, this pack runs about 23% above the cheapest pack (NDC 42799-0826-03, $4.16 vs $5.13 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 5 ml in 1 bottle.
What NDC number is used to bill for this package of Atropine sulfate 10 mg/mL Solution/ Drops?
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
Atropine 10 mg/mL 60219-1750-08 Amneal 1 bottle $4.162 AT1 Availability likely save 19%
Atropine sulfate 10 mg/mL 70069-0583-01 Somerset 1 bottle $4.162 AT1 Availability likely save 19%
Atropine Sulfate 10 mg/mL 70756-0653-35 Lifestar 1 bottle $4.162 AT1 Availability likely save 19%
Atropine sulfate 10 mg/mLthis 42799-0826-02 Edenbridge 1 bottle $5.134 AT1 Availability likely —
Atropine 10 mg/mL 60219-1749-03 Amneal 1 bottle $5.134 AT1 Availability likely —
Atropine sulfate 10 mg/mL 70069-0582-01 Somerset 1 bottle $5.134 AT1 Availability likely —
Atropine Sulfate 10 mg/mL 70756-0652-25 Lifestar 1 bottle $5.134 AT1 Availability likely —
Isopto Atropine 10 mg/mL 00065-0303-55 Alcon 1 bottle $9.701 AT2 Discontinued +89%
atropine sulfate 10 mg/mL 00065-0817-01 Alcon 1 bottle $10.345 AT2 Availability likely +102%
Atropine Sulfate 10 mg/mL 70069-0716-01 Somerset 1 bottle $10.345 AT2 Availability likely +102%
Atropine 10 mg/mL 60219-1748-02 Amneal 1 bottle $11.515 AT1 Availability likely +124%
Atropine 10 mg/mL 60505-6226-00 Apotex 1 bottle $11.515 AT1 Availability likely +124%
Atropine sulfate 10 mg/mL 70069-0581-01 Somerset 1 bottle $11.515 AT1 Availability likely +124%
Atropine Sulfate 10 mg/mL 70756-0651-25 Lifestar 1 bottle $11.515 AT1 Availability likely +124%
Atropine Sulfate 10 mg/mL 72603-0264-01 NorthStar 1 bottle $11.515 AT1 Availability likely +124%
Atropine Sulfate 10 mg/mL 24208-0965-01 Bausch 10 vials — — FDA listed —
Atropine 10 mg/mL 50090-7000-00 A-S 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 50090-7313-00 A-S 1 bottle — AT1 FDA listed —
Atropine Sulfate 10 mg/mL 67296-2124-05 Redpharm 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 67296-2200-05 Redpharm 1 bottle — AT1 FDA listed —
Atropine Sulfate 10 mg/mL 82260-0001-01 Bausch 10 vials — — FDA listed —
Atropine 10 mg/mL 68083-0671-01 Gland 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 68083-0669-01 Gland 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 68083-0670-01 Gland 1 bottle — AT1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 RN3152OP35
    Hypromellose is a plant-based thickener and film-former derived from cellulose. In medicines, it's used to create coatings on tablets and capsules, control how fast the drug dissolves, and improve the product's texture and stability.
  • 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.
  • UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 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

LabelerEdenbridge Pharmaceuticals LLC.
Application holderEDENBRIDGE PHARMACEUTICALS LLC
FDA applicationANDA219013 (ANDA)
Labeler code42799
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio43 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 79 words ▾

1 INDICATIONS AND USAGE Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: Atropine is an anticholinergic indicated in adults and pediatric patients aged three (3) months and older for: Cycloplegia ( 1.1 ) Mydriasis ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 )

1.1Cycloplegia .

1.2Mydriasis .

1.3Penalization of the Healthy Eye in the Treatment of Amblyopia .

⏱️ Dosage and Administration 88 words ▾

2 DOSAGE AND ADMINISTRATION Apply 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time. In adults and pediatric patients aged 3 years and older, doses may be repeated up to twice daily as needed. Apply 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time.

( 2 ) In adults and pediatric patients aged 3 years and older, doses may be repeated up to twice daily as needed. ( 2 )

💊 Dosage Forms and Strengths 18 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic Solution: 1% atropine sulfate. Ophthalmic solution: 1% atropine sulfate ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS Hypersensitivity or allergic reaction to any ingredient in formulation ( 4.1 )

4.1Hypersensitivity Atropine sulfate ophthalmic solution 1% is contraindicated in patients who have demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation.

⚠️ Warnings and Cautions 106 words ▾

5 WARNINGS AND PRECAUTIONS Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks. ( 5.1 ) Risk of blood pressure increase from systemic absorption. ( 5.2 )

5.1Photophobia and Blurred Vision Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.

5.2Elevation of Blood Pressure Elevation in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, 1%.

5.3Risk of Contamination Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Photophobia and Blurred Vision [ see Warnings and Precautions (5.1) ] Elevation in Blood Pressure [ see Warnings and Precautions (5.2) ] The following adverse reactions were identified in clinical studies or postmarketing reports following use of atropine sulfate ophthalmic solution. Because these reactions are 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.

Most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, decreased lacrimation, increased heart rate and blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Ocular Adverse Reactions Eye pain and stinging occurs upon instillation. Other commonly occurring adverse reactions include, blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and lid edema may also occur less commonly.

6.2Systemic Adverse Reactions Systemic effects of atropine are related to its anti-muscarinic activity. Systemic adverse events reported include dryness of skin, mouth, and throat from decreased secretions from mucus membranes; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.

🔄 Drug Interactions 53 words ▾

7 DRUG INTERACTIONS The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis. ( 7 )

7.1Monoamine oxidase inhibitors (MAOI) The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Should only be used in pregnant women if clearly needed. ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of atropine sulfate administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [ see Clinical Pharmacology (12.3) ].

Atropine sulfate ophthalmic solution 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

8.2Lactation Risk Summary There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of atropine sulfate to the mother. The effects on breastfed infants and the effects on milk production are also unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for atropine sulfate and any potential adverse effects on the breastfed child from atropine sulfate.

8.4Pediatric Use The safety and effectiveness of atropine sulfate ophthalmic solution 1% have been established in pediatric patients aged 3 months and older. Use of atropine sulfate ophthalmic solution 1% is supported by evidence from adequate and well-controlled trials with additional safety data from published literature. Due to the potential for systemic absorption, the use of atropine sulfate ophthalmic solution 1% in pediatric patients aged 3 months to 3 years should be limited to no more than one drop per eye per day.

Use in pediatric patients younger than 3 months of age is not recommended.

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

🤰 Pregnancy 76 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of atropine sulfate administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [ see Clinical Pharmacology (12.3) ].

Atropine sulfate ophthalmic solution 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 97 words ▾

8.4Pediatric Use The safety and effectiveness of atropine sulfate ophthalmic solution 1% have been established in pediatric patients aged 3 months and older. Use of atropine sulfate ophthalmic solution 1% is supported by evidence from adequate and well-controlled trials with additional safety data from published literature. Due to the potential for systemic absorption, the use of atropine sulfate ophthalmic solution 1% in pediatric patients aged 3 months to 3 years should be limited to no more than one drop per eye per day.

Use in pediatric patients younger than 3 months of age is not recommended.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

🆘 Overdosage 152 words ▾

10 OVERDOSAGE In the event of accidental ingestion or toxic overdosage with atropine sulfate ophthalmic solution, supportive care may include a short acting barbiturate or diazepam as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended.

Physostigmine, given by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required. Artificial respiration with oxygen may be necessary.

Cooling measures may be needed to help to reduce fever, especially in pediatric populations. The fatal adult dose of atropine is not known. In pediatric patients, 10 mg or less may be fatal.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atropine is a reversible antagonist of muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically.

Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors. The pupillary constrictor muscle depends on muscarinic cholinoceptor activation. This activation is blocked by topical atropine resulting in unopposed sympathetic dilator activity and mydriasis.

Atropine also weakens the contraction of the ciliary muscle, or cycloplegia. Cycloplegia results in loss of the ability to accommodate such that the eye cannot focus for near vision.

12.2Pharmacodynamics The onset of action after administration of atropine sulfate ophthalmic solution, 1%, is usually within 40 minutes with maximal effect being reached in about 2 hours. The effect can last for up to 2 weeks in a normal eye.

12.3Pharmacokinetics The bioavailability of atropine sulfate ophthalmic solution, 1% was assessed in six healthy subjects, 24 to 29 years of age. Subjects received either 0.3 mg atropine sulfate administered as bolus intravenous injection or 0.3 mg administered as 30 μl instilled unilaterally in the cul-de-sac of the eye. Plasma l-hyoscyamine concentrations were determined over selected intervals up to eight hours after dose administration.

The mean bioavailability of topically applied atropine was 63.5 ± 29% (range 19 to 95%) with large inter-individual differences. Mean maximum observed plasma concentration for the ophthalmic solution was 288 ± 73 pg/mL. Maximum concentration was reached in 28 ± 27 min after administration.

Terminal half-life of l-hyoscamine was not affected by route of administration and was calculated to be 3 ± 1.2 hours (intravenous) and 2.5 ± 0.8 hours (topical ophthalmic). In another placebo-controlled study, the systemic exposure to l-hyoscyamine, and the anti-cholinergic effects of atropine were investigated in eight ocular surgery patients 56 to 66 years of age, following single topical ocular 0.4 mg atropine dose (given as 40 microliters of atropine sulfate ophthalmic solution, 1%). The mean (± standard deviation (SD)) C max of l-hyoscyamine in these patients was 860 ± 402 pg/mL, achieved within 8 minutes of eyedrop instillation.

Following intravenous administration, the mean (± SD) elimination half-life (t 1/2 ) of atropine was reported to be longer in pediatric subjects under 2 years (6.9 ± 3.3 hours) and in geriatric patients 65 to 75 years (10 ± 7.3 hours), compared to in children over 2 years (2.5 ± 1.2 hours) and in adults 16 to 58 years (3 ± 0.9 hours). ( see Use in Specific Populations (8.4) ). Atropine is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine.

Traces are found in various secretions, including milk. The major metabolites of atropine are noratropine, atropin-n-oxide, tropine, and tropic acid. Atropine readily crosses the placental barrier and enters the fetal circulation but is not found in amniotic fluid.

Atropine binds poorly (about 44%) to plasma protein, mainly to alpha-1 acid glycoprotein; age has no effect on the serum protein binding of atropine. Atropine binding to α-1 acid glycoprotein was concentration dependent (2 to 20 mcg/mL) and nonlinear in vitro and in vivo . There is no gender effect on the pharmacokinetics of atropine administered by injection.

🧬 Mechanism of Action 113 words ▾

12.1Mechanism of Action Atropine is a reversible antagonist of muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically.

Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors. The pupillary constrictor muscle depends on muscarinic cholinoceptor activation. This activation is blocked by topical atropine resulting in unopposed sympathetic dilator activity and mydriasis.

Atropine also weakens the contraction of the ciliary muscle, or cycloplegia. Cycloplegia results in loss of the ability to accommodate such that the eye cannot focus for near vision.

📦 How Supplied / Storage and Handling 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atropine sulfate ophthalmic solution, USP 1% is supplied in a plastic dropper bottle with a red cap in the following sizes: NDC 42799-826-01 2 mL fill in 5mL bottle NDC 42799-826-02 5 mL fill in 5mL bottle NDC 42799-826-03 15 mL fill in 15mL bottle Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed. After opening, atropine sulfate ophthalmic solution can be used until the expiration date on the bottle.

📋 Description 121 words ▾

11 DESCRIPTION Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure: Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •H 2 O Molecular Weight: 694.83 g/mol Each mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine).

Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP. 1

💬 Information for Patients 86 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Contamination Advise patients not to touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution. Keep the bottle tightly closed. Instillation Site Pain Advise patients that drops will sting upon instillation.

Sensitivity to Light and Blurred Vision Advise patients that they will experience sensitivity to light and blurred vision which may last for a couple of weeks. Manufactured for: Edenbridge Pharmaceuticals, LLC DBA Dexcel Pharma USA Parsippany, NJ 07054 877-381-3336 Revision: 01/2026

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The bioavailability of atropine sulfate ophthalmic solution, 1% was assessed in six healthy subjects, 24 to 29 years of age. Subjects received either 0.3 mg atropine sulfate administered as bolus intravenous injection or 0.3 mg administered as 30 μl instilled unilaterally in the cul-de-sac of the eye. Plasma l-hyoscyamine concentrations were determined over selected intervals up to eight hours after dose administration.

The mean bioavailability of topically applied atropine was 63.5 ± 29% (range 19 to 95%) with large inter-individual differences. Mean maximum observed plasma concentration for the ophthalmic solution was 288 ± 73 pg/mL. Maximum concentration was reached in 28 ± 27 min after administration.

Terminal half-life of l-hyoscamine was not affected by route of administration and was calculated to be 3 ± 1.2 hours (intravenous) and 2.5 ± 0.8 hours (topical ophthalmic). In another placebo-controlled study, the systemic exposure to l-hyoscyamine, and the anti-cholinergic effects of atropine were investigated in eight ocular surgery patients 56 to 66 years of age, following single topical ocular 0.4 mg atropine dose (given as 40 microliters of atropine sulfate ophthalmic solution, 1%). The mean (± standard deviation (SD)) C max of l-hyoscyamine in these patients was 860 ± 402 pg/mL, achieved within 8 minutes of eyedrop instillation.

Following intravenous administration, the mean (± SD) elimination half-life (t 1/2 ) of atropine was reported to be longer in pediatric subjects under 2 years (6.9 ± 3.3 hours) and in geriatric patients 65 to 75 years (10 ± 7.3 hours), compared to in children over 2 years (2.5 ± 1.2 hours) and in adults 16 to 58 years (3 ± 0.9 hours). ( see Use in Specific Populations (8.4) ). Atropine is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine.

Traces are found in various secretions, including milk. The major metabolites of atropine are noratropine, atropin-n-oxide, tropine, and tropic acid. Atropine readily crosses the placental barrier and enters the fetal circulation but is not found in amniotic fluid.

Atropine binds poorly (about 44%) to plasma protein, mainly to alpha-1 acid glycoprotein; age has no effect on the serum protein binding of atropine. Atropine binding to α-1 acid glycoprotein was concentration dependent (2 to 20 mcg/mL) and nonlinear in vitro and in vivo . There is no gender effect on the pharmacokinetics of atropine administered by injection.

🧬 Pharmacodynamics 41 words ▾

12.2Pharmacodynamics The onset of action after administration of atropine sulfate ophthalmic solution, 1%, is usually within 40 minutes with maximal effect being reached in about 2 hours. The effect can last for up to 2 weeks in a normal eye.

🔬 Clinical Studies 68 words ▾

14 CLINICAL STUDIES Topical administration of atropine sulfate ophthalmic solution, 1% results in cycloplegia and mydriasis which has been demonstrated in several controlled clinical studies in adults and pediatric patients. Maximal mydriasis usually occurs in about 40 minutes and maximal cycloplegia is usually achieved in about 60 to 90 minutes after single administration. Full recovery usually occurs in approximately one week, but may last a couple of weeks.

🧪 Nonclinical Toxicology 48 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long term studies have not been performed to evaluate the carcinogenic potential of atropine sulfate. Mutagenesis Atropine sulfate was negative in the salmonella/microsome mutagenicity test. Impairment of Fertility Studies to evaluate impairment of fertility have not been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 45 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long term studies have not been performed to evaluate the carcinogenic potential of atropine sulfate. Mutagenesis Atropine sulfate was negative in the salmonella/microsome mutagenicity test. Impairment of Fertility Studies to evaluate impairment of fertility have not been conducted.

📄 Package Label / Principal Display Panel 10 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 1 1 1 1 1

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

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

Medicare Part D (outpatient prescription) spending for Atropine Sulfate — the program that covers self-administered drugs. 7 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 Atropine Sulfate. 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
$2.44M
Claims incl. refills
57.2K
Beneficiaries
42.2K
Spend / beneficiary
$57.89
Spend / claim
$42.70
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.
← 42799-0816-01 · Edenbridge 42799-0920-01 · Edenbridge →
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.