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Cyclopentolate Hydrochloride 10 mg/mL Solution, 2 mL — NDC 61314-0396-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cyclopentolate Hydrochloride 10 mg/mL Solution, 2 mL — NDC 61314-396-01 (Billing 61314-0396-01)

by Sandoz Inc. · 2 mL in 1 BOTTLE

This is a package of 2 mL of Cyclopentolate Hydrochloride 10 mg/mL Solution from Sandoz Inc., marketed since Aug 2002 and currently FDA-listed; retail pharmacies pay about $2.65 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 61314-0396-01
🏷️ FDA NDC (as labeled) 61314-396-01 billing pads the product segment with a zero
This package
Contains2 mL Cost per mL$2.65 NADAC Per package$5.29 / 2 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $5.25/unit — full pricing hub ↓
Main listing for product 61314-396 · Also comes in: 5 ml 61314-396-02 15 ml 61314-396-03
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 61314-396-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61314 labeler · 396 product · 01 package
Package marketed since
Aug 22, 2002
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
2 mL per package
Barcode (UPC)
0361314396037
Medicaid fills, this package
13,942 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61314-396-01
Product NDC 61314-396
11-digit billing NDC 61314039601
NCPDP billing unit ML — per mL (volume)
RxCUI 1298066
UNII 736I6971TE
UPC 0361314396037
Application # ANDA084110
SPL Set ID c1b44f91-356d-4804-9509-3b457f4809e5
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-08-22
Route OPHTHALMIC
Dosage form SOLUTION
Substance CYCLOPENTOLATE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 86350020102010
GPI class Cyclopentolate HCl
GCN Seq No 007875
GCN 33031
HICL code 003467
Ingredient (HICL) Cyclopentolate Hcl
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 52:24.00.00
AHFS class Mydriatics
FDB label name CYCLOPENTOLATE 1% EYE DROPS
FDB brand name Cyclopentolate Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007875
  • GCN: 33031
  • GPI-14 (Medi-Span): 86350020102010
  • HICL (First Databank): 003467
  • AHFS class code: 52:24.00.00
  • RxCUI (RxNorm): 1298066
Why two NDCs? The FDA registers this code as 61314-396-01 — 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 → 61314-0396-01. 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 Anticholinergics class.

Drug family (ATC) Anticholinergics
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 CYCLOPENTOLATE 1% EYE DROPS Ingredient Cyclopentolate Hcl
📖 What it is MedlinePlus · NLM

Cyclopentolate ophthalmic is used to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle of the eye) before an eye examination. Cyclopentolate is in a class of medications called mydriatics. Cyclopentolate works by blocking certain receptors found in the eye to temporarily relax or provide short-term paralysis of the eye muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • These drops dilate your pupils and temporarily stop your eyes from auto-focusing, so your doctor can see the full back of your eye and get an accurate reading of your prescription....
  • Why did my eye doctor put these drops in my eyes before my exam?
  • Blurry vision and light sensitivity are completely expected after these drops and are part of how the medication works. For most adults, things return to normal within 24 hours. Pu...
  • How long will my vision be blurry and my eyes sensitive to light?
📖 Read our full Cyclopentolate Ophthalmic guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $2.645 $5.29 / 2 ml
Medicaid paysCMS SDUD · 12 mo $5.25 $10.49 / 2 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Jan 2026 Sep 2026 $3.393 $2.179
▼ Down 22% over the last 23 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
61314-0396-01 You're viewing this Main listing 2 mL in 1 BOTTLE $2.65 / mL $5.29 2002-08-22 — Active
61314-0396-02 61314-396-02 5 mL in 1 BOTTLE — — 2002-08-22 — Active
61314-0396-03 61314-396-03 15 mL in 1 BOTTLE $0.8698 / mL $13.05 2002-08-22 — Active

You're viewing the smallest of 3 pack sizes for this product.

Per mL, this pack runs about 204% above the cheapest pack (15 mL, $0.8698 vs $2.65 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 89% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 2 mL — 2 ml in 1 bottle.
How does this package differ from NDC 61314-0396-02?
Both are Cyclopentolate Hydrochloride 10 mg/mL Solution — the drug itself is identical. This page's package is the 2 mL one, while NDC 61314-0396-02 is the 5 ml package.
What NDC number is used to bill for this package of Cyclopentolate Hydrochloride 10 mg/mL Solution?
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
Cyclopentolate Hydrochloride 10 mg/mL 24208-0735-01 Bausch 1 bottle $2.645 AT Availability likely —
Cyclopentolate Hydrochloride 10 mg/mLthis 61314-0396-01 Sandoz 2 ml $2.645 AT Availability likely —
Cyclogyl 10 mg/mL 00065-0396-02 Alcon 1 bottle — AT 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

🏛️
2002
On the market since
Aug 2002
📍
2026
Currently FDA-listed
24 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.

🧪 Avoiding an ingredient? See Cyclopentolate Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • 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 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • 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.

7 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

LabelerSandoz Inc.
Application holderALCON LABORATORIES INC
FDA applicationANDA084110 (ANDA)
Labeler code61314
First marketedAug 2002
Product typeHuman Prescription Drug
Portfolio50 products on file

More NDCs from Sandoz Inc. labeler code 61314

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

INDICATIONS AND USAGE Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

⏱️ Dosage and Administration 132 words ▾

DOSAGE AND ADMINISTRATION Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days.

Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% Cyclopentolate Hydrochloride Ophthalmic Solution in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes.

Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Should not be used if the patient is hypersensitive to any component of this preparation.

⚠️ Warnings 123 words ▾

WARNINGS For topical ophthalmic use. Not for injection. This preparation may cause Central Nervous System (CNS) disturbances.

This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of 0.5% cyclopentolate hydrochloride ophthalmic solution, USP per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes.

Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure. Patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.

Mydriatics may produce a transient elevation of intraocular pressure.

🤒 Adverse Reactions 130 words ▾

ADVERSE REACTIONS Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people.

This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.

🔄 Drug Interactions 17 words ▾

Drug Interactions Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

🤰 Pregnancy 45 words ▾

Pregnancy Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed.

🧒 Pediatric Use 117 words ▾

Pediatric Use Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people.

Feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants may follow ophthalmic use of this product. Cases of NEC have been reported in preterm infants following administration; however, causality has not been established. It is recommended that feeding be withheld for four (4) hours after examination in infants.

Observe infants closely for at least 30 minutes (See WARNINGS ).

🧓 Geriatric Use 14 words ▾

Geriatric Use No overall differences in safety or effectiveness between elderly and younger patients.

🆘 Overdosage 43 words ▾

OVERDOSAGE Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

🧬 Clinical Pharmacology 87 words ▾

CLINICAL PHARMACOLOGY This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation.

Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED In multiple-dose plastic DROP-TAINER* dispensers: Cyclopentolate Hydrochloride Ophthalmic Solution USP 0.5% 1% 2% 15 mL NDC 61314-395-01 2 mL NDC 61314-396-01 2 mL NDC 61314-397-01 5 mL NDC 61314-396-02 5 mL NDC 61314-397-02 15 mL NDC 61314-396-03 15 mL NDC 61314-397-03 Storage: Store at 8° to 25°C (46° to 77°F). After opening, cyclopentolate hydrochloride can be used until the expiration date on the bottle. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rx Only

📋 Description 93 words ▾

DESCRIPTION Cyclopentolate Hydrochloride Ophthalmic Solution USP is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. It is supplied in three strengths. The active ingredient is represented by the structural formula: Established name: Cyclopentolate Hydrochloride Chemical name: 2-(Dimethylamino)ethyl 1-hydroxy-a-phenylcyclopentaneacetate hydrochloride Each mL of cyclopentolate hydrochloride ophthalmic solution, USP contains: Active: cyclopentolate hydrochloride 0.5%, 1% or 2%.

Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5. chemical

💬 Information for Patients 108 words ▾

Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated.

Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants.

It is recommended that feeding be withheld for four (4) hours after examination in infants.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution.

A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.

Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination in infants.

Drug Interactions Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of Cyclopentolate Hydrochloride Ophthalmic Solution USP. Pregnancy Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate.

It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when cyclopentolate hydrochloride is administered to a nursing woman. Pediatric Use Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage.

These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants may follow ophthalmic use of this product. Cases of NEC have been reported in preterm infants following administration; however, causality has not been established.

It is recommended that feeding be withheld for four (4) hours after examination in infants. Observe infants closely for at least 30 minutes (See WARNINGS ). Geriatric Use No overall differences in safety or effectiveness between elderly and younger patients.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cyclopentolate hydrochloride is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of Cyclopentolate Hydrochloride Ophthalmic Solution USP.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL NDC 61314-396-03 Cyclopentolate Hydrochloride 0phthalmic Solution, USP 1% Rx only STERILE 15 mL SANDOZ a Novartis company INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water.

The pH range is between 3.0 and 5.5. USUAL DOSAGE: Instill one or two drops in the eye which may be repeated in five to ten minutes if necessary. Read enclosed insert.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 8° to 25°C (46° to 77°F). Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA Rev. 10/2015 9012233-0915 LOT: EXP.: NDC 61314-396-03 Cyclopentolate Hydrochloride 0phthalmic Solution, USP 1% FOR TOPICAL OPHTHALMIC USE ONLY Rx only STERILE 15 mL SANDOZ INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 1%.

Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, potassium chloride, edetate disodium, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. Rev. 10/2015 USUAL DOSAGE: Instill one or two drops in the eye which may be repeated in five to ten minutes if necessary.

Read enclosed insert. STORAGE: Store at 8° to 25°C (46° to 77°F). Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA H14037-0915 LOT/EXP.: NDC 61314-396-03 Cyclopentolate Hydrochloride 0phthalmic Solution, USP 1% Rx only STERILE 15 mL SANDOZ a Novartis company INGREDIENTS: Each mL contains : Active: cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.

Inactives : boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5. USUAL DOSAGE: Instill one or two drops in the eye which may be repeated in five to ten minutes if necessary.

Read enclosed insert. FOR TOPICAL OPHTHALMIC USE ONLY. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

STORAGE: Store at 8° to 25°C (46° to 77°F). After opening, cyclopentolate hydrochloride can be used until the expiration date on the bottle. KEEP OUT OF THE REACH OF CHILDREN Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Product of Spain Rev. 01/2021 300047036 -0121 NDC 61314-396-03 Cyclopentolate Hydrochloride 0phthalmic Solution, USP 1% FOR TOPICAL OPHTHALMIC USE ONLY Rx only STERILE 15 mL SANDOZ INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 1%.

Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, potassium chloride, edetate disodium, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. Rev. 03/2016 USUAL DOSAGE: Instill one or two drops in the eye which may be repeated in five to ten minutes if necessary.

Read enclosed insert. STORAGE: Store at 8° to 25°C (46° to 77°F). Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA H14265-0216 LOT/EXP.:

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
13.9K
Units reimbursed last 4 qtrs
36.9K
Gross reimbursed last 4 qtrs
$193.3K
Avg / prescription
$13.87
Avg / unit
$5.2455
Latest quarter Q1 2026
3.2KRx
Medicaid pays / mL
$5.2455
gross reimbursed
vs
NADAC / mL
$2.6453
acquisition cost
=
Spread
+$2.6002
+98% 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 ⓘ
55% FFS 45% MCO
Fee-for-service · 7,651 Rx Managed care · 6,291 Rx
State Medicaid map
Alaska: no data reported AK Maine: 146 units · 10.5 per 100k residents ME Washington: 28 units · 0.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 337 units · 5.9 per 100k residents MN Wisconsin: 784 units · 13.3 per 100k residents WI Michigan: 1,346 units · 13.4 per 100k residents MI New York: 7,128 units · 36.4 per 100k residents NY Vermont: no data reported VT New Hampshire: 142 units · 10.1 per 100k residents NH Oregon: 308 units · 7.3 per 100k residents OR Nevada: 32 units · 1.0 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 172 units · 5.4 per 100k residents IA Illinois: 1,568 units · 12.5 per 100k residents IL Indiana: 297 units · 4.3 per 100k residents IN Ohio: 1,712 units · 14.5 per 100k residents OH Pennsylvania: 2,803 units · 21.6 per 100k residents PA New Jersey: 1,479 units · 15.9 per 100k residents NJ Massachusetts: 1,362 units · 19.5 per 100k residents MA California: 8,686 units · 22.3 per 100k residents CA Utah: no data reported UT Colorado: 630 units · 10.7 per 100k residents CO Nebraska: no data reported NE Missouri: 588 units · 9.5 per 100k residents MO Kentucky: 710 units · 15.7 per 100k residents KY West Virginia: 196 units · 11.1 per 100k residents WV Virginia: 590 units · 6.8 per 100k residents VA Maryland: 578 units · 9.4 per 100k residents MD Connecticut: 938 units · 25.9 per 100k residents CT Rhode Island: 344 units · 31.4 per 100k residents RI Arizona: 460 units · 6.2 per 100k residents AZ New Mexico: no data reported NM Kansas: 56 units · 1.9 per 100k residents KS Arkansas: 56 units · 1.8 per 100k residents AR Tennessee: 338 units · 4.7 per 100k residents TN North Carolina: 902 units · 8.3 per 100k residents NC South Carolina: 360 units · 6.7 per 100k residents SC Delaware: 210 units · 20.4 per 100k residents DE Oklahoma: 278 units · 6.9 per 100k residents OK Louisiana: 380 units · 8.3 per 100k residents LA Mississippi: no data reported MS Alabama: 202 units · 4.0 per 100k residents AL Georgia: 379 units · 3.4 per 100k residents GA D.C.: no data reported DC Hawaii: 72 units · 5.0 per 100k residents HI Texas: no data reported TX Florida: 262 units · 1.2 per 100k residents FL
Units reimbursed · per 100k residents
0.436.4
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 36.4 /100k
2 Rhode Island 31.4 /100k
3 Connecticut 25.9 /100k
4 California 22.3 /100k
5 Pennsylvania 21.6 /100k
6 Delaware 20.4 /100k
7 Massachusetts 19.5 /100k
8 New Jersey 15.9 /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.
2 ml this page61314-0396-01 13,942 Rx · $193,344
15 ml61314-0396-03 1,654 Rx · $38,639
5 ml61314-0396-02 No Medicaid data
Drug total (last 4 qtrs): 15,596 Rx · 61,604 units · $231,982 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 61314-0391-64 · Sandoz 61314-0454-20 · Sandoz →
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.