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Atropine Sulfate 10 mg/mL Solution/ Drops — NDC 72603-264-02 (Billing 72603-0264-02)

by NorthStar RxLLC · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Atropine Sulfate 10 mg/mL Solution/ Drops from NorthStar RxLLC, marketed since Sep 2024 and currently FDA-listed; retail pharmacies pay about $5.13 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 72603-0264-02
🏷️ FDA NDC (as labeled) 72603-264-02 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 sizes2 compare ↓
Also priced by: Medicaid pays $7.53/unit · Part D plans $7.91/unit — full pricing hub ↓
Main listing for product 72603-264 · Also comes in: 2 mL 72603-264-01
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) 72603-264-02
Product NDC 72603-264
11-digit billing NDC 72603026402
NCPDP billing unit ML — per mL (volume)
RxCUI 1190655
UNII 03J5ZE7KA5
UPC 0372603264029, 0372603264012
Application # ANDA218148
SPL Set ID f750135c-e6bf-4aa7-a343-87b1204df94f
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 2024-09-01
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 DROPS
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 72603-264-02 — 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 → 72603-0264-02. 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 DROPS 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 $7.53 $37.67 / 5 ml
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
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $6.956 $5.134
▼ Down 26% over the last 10 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
72603-0264-01 72603-264-01 1 BOTTLE in 1 CARTON / 2 mL in 1 BOTTLE $11.51 / mL $23.03 2024-09-01 — Active
72603-0264-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE $5.13 / mL $25.67 2024-09-01 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($5.13 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 82% of fills over the last four reported quarters. See all packs ↓

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 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 —
Atropine Sulfate 10 mg/mLthis 72603-0264-02 NorthStar 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 sulfate 10 mg/mL 42799-0826-01 Edenbridge 1 bottle $11.515 AT1 Availability likely +124%
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 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
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.

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

LabelerNorthStar RxLLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA218148 (ANDA)
Labeler code72603
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio308 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 70 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)

1.1 Cycloplegia

1.2 Mydriasis

1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia

⏱️ Dosage and Administration 84 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 30 words ▾

3 DOSAGE FORMS AND STRENGTHS Atropine Sulfate Ophthalmic Solution, USP 1%: each mL contains 10 mg of atropine sulfate equivalent to 8.3 mg of atropine Ophthalmic solution: 1% atropine sulfate

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS Hypersensitivity or allergic reaction to any ingredient in formulation.

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 102 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 Elevations 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 218 words ▾

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. To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 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 50 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.

7.1Monoamine 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.

8.1Pregnancy 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.

🆘 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 (10.0 ± 7.3 hours), compared to in children over 2 years (2.5 ± 1.2 hours) and in adults 16 to 58 years (3.0 ± 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.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Ophthalmic Solution, USP 1% is supplied as clear, colorless solution in a three piece white bottle with a natural nozzle and red cap in the following sizes: NDC 72603-264-01 2 mL fill in 5 mL bottle NDC 72603-264-02 5 mL fill in 5 mL bottle Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. After opening, Atropine Sulfate Ophthalmic Solution can be used until the expiration date on the bottle.

📋 Description 153 words ▾

11 DESCRIPTION Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for 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: 694.84 g/mol Atropine sulfate, USP appears as colorless, almost white to white solid.

It is very soluble in water and glacial acetic acid, freely soluble in ethanol (96%) and practically insoluble in diethyl ether. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active : atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate anhydrous, edetate disodium dihydrate, hypromellose (2910), monobasic sodium phosphate monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP. structure

💬 Information for Patients 93 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Contamination Advise patients to not 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: NorthstarRxLLC Memphis, TN 38141. Manufactured by: Mankind Pharma Limited Paonta Sahib, Sinnaur Himachal Pradesh 173025, India.

Revised: September 2025, V-02

🔬 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 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long term studies in animals 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 60 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72603-264-01 Atropine Sulfate Ophthalmic Solution, USP 1% 2 mL Rx only Sterile NDC 72603-264-01 Atropine Sulfate Ophthalmic Solution, USP 1% 2 mL Rx only Sterile NDC 72603-264-02 Atropine Sulfate Ophthalmic Solution, USP 1% 5 mL Rx only Sterile NDC 72603-264-02 Atropine Sulfate Ophthalmic Solution, USP 1% 5 mL Rx only Sterile 2mlbottlelabel 2mlcartonlabel 5mlbottlelabel 5mlcartonlabel

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 – Q4 2025 · 4 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
2.1K
Units reimbursed last 4 qtrs
12.3K
Gross reimbursed last 4 qtrs
$92.5K
Avg / prescription
$44.47
Avg / unit
$7.5339
Latest quarter Q4 2025
687Rx
Medicaid pays / mL
$7.5339
gross reimbursed
vs
NADAC / mL
$5.1339
acquisition cost
=
Spread
+$2.4000
+47% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 888 Rx Managed care · 1,191 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,035 units · 13.2 per 100k residents WA Idaho: 75 units · 3.8 per 100k residents ID Montana: 75 units · 6.6 per 100k residents MT North Dakota: no data reported ND Minnesota: 695 units · 12.1 per 100k residents MN Wisconsin: 70 units · 1.2 per 100k residents WI Michigan: 125 units · 1.2 per 100k residents MI New York: 1,520 units · 7.8 per 100k residents NY Vermont: no data reported VT New Hampshire: 60 units · 4.3 per 100k residents NH Oregon: 500 units · 11.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 285 units · 2.3 per 100k residents IL Indiana: no data reported IN Ohio: 1,127 units · 9.6 per 100k residents OH Pennsylvania: 635 units · 4.9 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 75 units · 1.1 per 100k residents MA California: 1,980 units · 5.1 per 100k residents CA Utah: no data reported UT Colorado: 810 units · 13.8 per 100k residents CO Nebraska: 70 units · 3.5 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 60 units · 1.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 215 units · 2.9 per 100k residents 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: 465 units · 9.1 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,394 units · 7.8 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.013.8
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 Colorado 13.8 /100k
2 Washington 13.2 /100k
3 Minnesota 12.1 /100k
4 Oregon 11.8 /100k
5 Ohio 9.6 /100k
6 Alabama 9.1 /100k
7 Texas 7.8 /100k
8 New York 7.8 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page72603-0264-02 2,079 Rx · $92,452
1 bottle72603-0264-01 461 Rx · $11,789
Drug total (last 4 qtrs): 2,540 Rx · 13,326 units · $104,241 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for 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.
← 72603-0263-02 · NorthStar 72603-0265-01 · Northstar →
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.