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Atropine Sulfate 10 mg/mL Solution, 10 vials — NDC 82260-001-01 (Billing 82260-0001-01)

by Bausch & Lomb Americas Inc. · 10 VIAL in 1 CARTON / .4 mL in 1 VIAL

This is a package of 10 vials of Atropine Sulfate 10 mg/mL Solution from Bausch & Lomb Americas Inc., marketed since Apr 2023 and currently FDA-listed. It is this product's only package size.

NDC 82260-0001-01
🏷️ FDA NDC (as labeled) 82260-001-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 82260-001-01
Product NDC 82260-001
11-digit billing NDC 82260000101
NCPDP billing unit EA — each (per item)
RxCUI 1190655
UNII 03J5ZE7KA5
Application # NDA213581
SPL Set ID e294ce2b-6bb5-4f84-8a6d-ce2402ed926d
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-21
Route OPHTHALMIC
Dosage form SOLUTION
Substance ATROPINE SULFATE

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

GPI-14 86350010102010
GCN Seq No 061062
GCN 27224
HICL code 033836
Ingredient (HICL) Atropine Sulfate/Pf
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 DROPS
FDB brand name Atropine Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 061062
  • GCN: 27224
  • GPI-14 (Medi-Span): 86350010102010
  • HICL (First Databank): 033836
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1190655
Why two NDCs? The FDA registers this code as 82260-001-01 — 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 → 82260-0001-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the 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 DROPS Ingredient Atropine Sulfate/Pf
📗 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $4.92 $19.69 / 4 ml
Medicare drug plans payPart D · Q2 2026 $7.91 $31.62 / 4 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82260-0001-01 You're viewing this Main listing 10 VIAL in 1 CARTON / .4 mL in 1 VIAL 2023-04-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atropine 10 mg/mL 60219-1750-08 Amneal 1 bottle $4.162 AT1 Availability likely —
Atropine sulfate 10 mg/mL 70069-0583-01 Somerset 1 bottle $4.162 AT1 Availability likely —
Atropine Sulfate 10 mg/mL 70756-0653-35 Lifestar 1 bottle $4.162 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 —
atropine sulfate 10 mg/mL 00065-0817-01 Alcon 1 bottle $10.345 AT2 Availability likely —
Atropine Sulfate 10 mg/mL 70069-0716-01 Somerset 1 bottle $10.345 AT2 Availability likely —
Atropine sulfate 10 mg/mL 42799-0826-01 Edenbridge 1 bottle $11.515 AT1 Availability likely —
Atropine 10 mg/mL 60219-1748-02 Amneal 1 bottle $11.515 AT1 Availability likely —
Atropine 10 mg/mL 60505-6226-00 Apotex 1 bottle $11.515 AT1 Availability likely —
Atropine sulfate 10 mg/mL 70069-0581-01 Somerset 1 bottle $11.515 AT1 Availability likely —
Atropine Sulfate 10 mg/mL 70756-0651-25 Lifestar 1 bottle $11.515 AT1 Availability likely —
Atropine Sulfate 10 mg/mL 72603-0264-01 NorthStar 1 bottle $11.515 AT1 Availability likely —
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/mLthis 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 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerBausch & Lomb Americas Inc.
Application holderBAUSCH AND LOMB INC
FDA applicationNDA213581 (NDA AUTHORIZED GENERIC)
Labeler code82260
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio18 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 56 words ▾

1 INDICATIONS AND USAGE Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 )

1.1 Mydriasis

1.2 Cycloplegia

1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia

⏱️ Dosage and Administration 117 words ▾

2 DOSAGE AND ADMINISTRATION In individuals from three (3) months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva in one or both eyes as indicated, forty minutes prior to the intended maximal dilation time. In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. Discard the single-dose vial immediately after use in one or both eyes.

In individuals from three (3) months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time (2.1). In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed (2.2).

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Atropine Sulfate Ophthalmic Solution, USP 1%: each mL contains 10 mg of atropine sulfate. Ophthalmic solution: 1% atropine sulfate (10 mg/mL) ( 3 ).

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Atropine Sulfate Ophthalmic Solution, USP 1% should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. Hypersensitivity or allergic reaction to any ingredient in the formulation ( 4 ).

⚠️ Warnings and Cautions 147 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 ). To avoid the potential for eye injury or contamination, care should be taken to avoid touching the single-dose vial to the eye or to any other surface ( 5.3 ).

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, USP 1%.

5.3Potential for Eye Injury or Contamination To avoid the potential for eye injury or contamination, care should be taken to avoid touching the single-dose vial to the eye or to any other surface.

🤒 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 have been identified 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, superficial keratitis, decreased lacrimation, drowsiness, increased heart rate and blood pressure ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Ocular Adverse Reactions Eye pain and stinging occurs upon instillation of atropine sulfate ophthalmic solution. Other commonly occurring adverse reactions include blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and eyelid 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 mucous membranes; drowsiness, 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

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of Atropine Sulfate Ophthalmic Solution, USP 1% 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, USP 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 administrations of Atropine Sulfate Ophthalmic Solution, USP 1% 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 Ophthalmic Solution, USP 1% and any potential adverse effects on the breastfed child from Atropine Sulfate Ophthalmic Solution, USP 1%.

8.4Pediatric Use Due to the potential for systemic absorption, the use of Atropine Sulfate Ophthalmic Solution, USP 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. Safety and efficacy in children above the age of 3 months has been established in adequate and well controlled trials.

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

🤰 Pregnancy 81 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of Atropine Sulfate Ophthalmic Solution, USP 1% 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, USP 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 73 words ▾

8.4Pediatric Use Due to the potential for systemic absorption, the use of Atropine Sulfate Ophthalmic Solution, USP 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. Safety and efficacy in children above the age of 3 months has been established in adequate and well controlled trials.

🧓 Geriatric Use 19 words ▾

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

🆘 Overdosage 154 words ▾

10 OVERDOSAGE In the event of accidental ingestion or toxic overdosage with Atropine Sulfate Ophthalmic Solution, USP 1%, 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 populations, 10 mg or less may be fatal.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atropine is a reversible antagonist of muscarine-like actions of acetylcholine and is therefore classified as an anti-muscarinic 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, USP 1% generally occurs within minutes with maximal effect seen in hours and the effect can last multiple days [see Clinical Studies (14) ] .

12.3Pharmacokinetics In a study of healthy subjects, after topical ocular administration of 30 μL of atropine sulfate ophthalmic solution 1%, the mean (± SD) systemic bioavailability of l-hyoscyamine was reported to be approximately 64 ± 29% (range 19% to 95%) as compared to intravenous administration of atropine sulfate. The median (range) time to maximum plasma concentration (Tmax) was 19 minutes (range 3 to 60 minutes), and the mean (±SD) peak plasma concentration (Cmax) of l-hyoscyamine was 288 ± 73 pg/mL. The mean (±SD) plasma half-life was reported to be approximately 2.5 ± 0.8 hours.

In a separate study of patients undergoing ocular surgery, after topical ocular administration of 40 μL of atropine sulfate ophthalmic solution, 1%, the mean (± SD) plasma Cmax of l-hyoscyamine was 860 ± 402 pg/mL, which was observed within 8 minutes following administration.

🧬 Mechanism of Action 113 words ▾

12.1Mechanism of Action Atropine is a reversible antagonist of muscarine-like actions of acetylcholine and is therefore classified as an anti-muscarinic 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 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Ophthalmic Solution, USP 1% is supplied as an aseptically prepared, sterile solution for topical ophthalmic use supplied as a 0.4 mL fill in a translucent, low-density polyethylene, single-dose vial. One (1) strip of 5 single-dose vials is packaged into a foil pouch. NDC 82260-001-01 10 single-dose vials.

2 foil pouches each containing one strip of 5 single-dose vials. Storage and Handling: Store at 20°C to 25°C (68°F to 77°F). Store single-dose vials in the foil pouches.

Opened vials cannot be resealed and should be discarded immediately after use.

📋 Description 117 words ▾

11 DESCRIPTION Atropine Sulfate Ophthalmic Solution, USP 1% is an aseptically prepared, sterile solution for topical ophthalmic use. The product does not contain an antimicrobial preservative. 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: 694.84 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: boric acid, hydroxypropyl methylcellulose, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP. chemstructure

💬 Information for Patients 149 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients that drops will sting upon instillation that they may experience blurry vision and sensitivity to light and should protect their eyes in bright illumination during dilation. These effects may last up to a couple weeks. Advise patients to keep the single-dose vials in the foil pouches until ready to use.

The solution from one single-dose vial is to be used immediately after opening to dose one or both eye(s) of a single patient. The single-dose vial, including any remaining contents, should be discarded immediately after administration [see Dosage and Administration (2) ] . Advise patients not to touch the tip of the single-dose vial to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA © 2022 Bausch & Lomb Incorporated or its affiliates 9775600

🧬 Pharmacokinetics 138 words ▾

12.3Pharmacokinetics In a study of healthy subjects, after topical ocular administration of 30 μL of atropine sulfate ophthalmic solution 1%, the mean (± SD) systemic bioavailability of l-hyoscyamine was reported to be approximately 64 ± 29% (range 19% to 95%) as compared to intravenous administration of atropine sulfate. The median (range) time to maximum plasma concentration (Tmax) was 19 minutes (range 3 to 60 minutes), and the mean (±SD) peak plasma concentration (Cmax) of l-hyoscyamine was 288 ± 73 pg/mL. The mean (±SD) plasma half-life was reported to be approximately 2.5 ± 0.8 hours.

In a separate study of patients undergoing ocular surgery, after topical ocular administration of 40 μL of atropine sulfate ophthalmic solution, 1%, the mean (± SD) plasma Cmax of l-hyoscyamine was 860 ± 402 pg/mL, which was observed within 8 minutes following administration.

🧬 Pharmacodynamics 38 words ▾

12.2Pharmacodynamics The onset of action after administration of Atropine Sulfate Ophthalmic Solution, USP 1% generally occurs within minutes with maximal effect seen in hours and the effect can last multiple days [see Clinical Studies (14) ] .

🔬 Clinical Studies 62 words ▾

14 CLINICAL STUDIES Topical administration of Atropine Sulfate Ophthalmic Solution, USP 1% results in mydriasis and/or cycloplegia with efficacy demonstrated in both adults and children. The maximum effect for mydriasis is achieved in about 30–40 minutes after administration, with recovery after approximately 7–10 days. The maximum effect for cycloplegia is achieved within 60–180 minutes after administration, with recovery after approximately 7–12 days.

🧪 Nonclinical Toxicology 31 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Atropine sulfate was negative in the Salmonella /microsome mutagenicity test. Studies to evaluate carcinogenicity and impairment of fertility have not been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 28 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Atropine sulfate was negative in the Salmonella /microsome mutagenicity test. Studies to evaluate carcinogenicity and impairment of fertility have not been conducted.

📄 Package Label / Principal Display Panel 35 words ▾

Package/Label Display Panel NDC 82260-001-01 Atropine Sulfate Ophthalmic Solution, USP 1% Sterile FOR TOPICAL OPHTHALMIC USE NOT FOR INJECTION EYE IMAGE Rx only 10 x 0.4 mL Single-Dose Vials BAUSCH + LOMB 9769201 AG CARTON

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11
Units reimbursed last 4 qtrs
104
Gross reimbursed last 4 qtrs
$512.05
Avg / prescription
$46.55
Avg / unit
$4.9236
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 11 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 104 units · 0.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.50.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 0.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bausch & Lomb Americas Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bausch & Lomb Americas Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 82249-0747-60 · CivicaScript 82260-0045-05 · Bausch →
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.