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Pilocarpine Hydrochloride 20 mg/mL Solution/ Drops — NDC 61314-0204-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pilocarpine Hydrochloride 20 mg/mL Solution/ Drops — NDC 61314-204-15 (Billing 61314-0204-15)

by Sandoz Inc · 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of Pilocarpine Hydrochloride 20 mg/mL Solution/ Drops from Sandoz Inc, marketed since Sep 2011 and currently FDA-listed; retail pharmacies pay about $2.81 per mL (NADAC). It is this product's only package size.

NDC 61314-0204-15
🏷️ FDA NDC (as labeled) 61314-204-15 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

NDC database record

One package, one record: these facts belong to NDC 61314-204-15 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61314 labeler · 204 product · 15 package
Package marketed since
Sep 30, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6131420415 8
Medicaid fills, this package
309 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) 61314-204-15
Product NDC 61314-204
11-digit billing NDC 61314020415
NCPDP billing unit ML — per mL (volume)
RxCUI 1000647, 1000862, 1000897
UNII 0WW6D218XJ
Application # NDA200890
SPL Set ID 53fa0b7a-f982-48a7-92c4-6f098683c1ed
Established class (EPC) Cholinergic Receptor Agonist
Mechanism of action Cholinergic Agonists; Cholinergic Muscarinic Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-09-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PILOCARPINE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 86501030102020
GPI class Pilocarpine HCl
GCN Seq No 007824
GCN 32706
HICL code 005198
Ingredient (HICL) Pilocarpine 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 Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name PILOCARPINE 2% EYE DROPS
FDB brand name Pilocarpine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007824
  • GCN: 32706
  • GPI-14 (Medi-Span): 86501030102020
  • HICL (First Databank): 005198
  • AHFS class code: 12:04.00.00
  • RxCUI (RxNorm): 1000647
Why two NDCs? The FDA registers this code as 61314-204-15 — 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 → 61314-0204-15. 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 Cholinergic Receptor Agonist class.

Pharmacologic class Cholinergic Receptor Agonist
Drug family (ATC) Other parasympathomimetics, Parasympathomimetics
How it works Cholinergic Muscarinic Agonists, Cholinergic Agonists
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 PILOCARPINE 2% EYE DROPS Ingredient Pilocarpine Hcl
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Eye drops are used for glaucoma, raised eye pressure or presbyopia, depending on the brand. Tablets treat dry mouth from head and neck radiation or Sjogr...
  • Eye drops go in the eye and tablets are swallowed. Schedules vary by product, so follow your prescriber and your label. For dry mouth, it can take weeks to know if the tablets are...
  • With tablets, sweating is the most common, along with nausea, runny nose, diarrhea and chills. Eye forms can blur your vision, especially at night. Call your doctor if effects are...
  • Use extra caution. Tablets should not be used with uncontrolled asthma. With controlled asthma, COPD, chronic bronchitis or significant heart disease, you would need close supervis...
📖 Read our full Pilocarpine 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 $2.814 $42.22 / 15 ml
Medicaid paysCMS SDUD · 12 mo $4.34 $65.10 / 15 ml
Medicare drug plans payPart D · Q2 2026 $4.13 $61.95 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $4.334 $2.814
▼ Down 32% over the last 24 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 Marketing startMarketing endStatus
61314-0204-15 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE 1996-02-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pilocarpine Hydrochloride 20 mg/mLthis 61314-0204-15 Sandoz 1 bottle $2.814 AT Availability likely —
Pilocarpine Hydrochloride 20 mg/mL 69238-1746-08 Amneal 1 bottle $2.814 AT Availability likely —
Pilocarpine Hydrochloride 20 mg/mL 70069-0191-01 Somerset 1 bottle $2.814 AT Availability likely —
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

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationNDA200890 (NDA AUTHORIZED GENERIC)
Labeler code61314
First marketedSep 2011
Product typeHuman Prescription Drug
Portfolio391 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 113 words ▾

1 INDICATIONS AND USAGE Pilocarpine hydrochloride ophthalmic solution is indicated for the: Pilocarpine hydrochloride ophthalmic solution is a muscarinic cholinergic agonist indicated for: • The reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1.1 ) • The management of acute angle-closure glaucoma. ( 1.2 ) • The prevention of postoperative elevated IOP associated with laser surgery.

( 1.3 ) • The induction of miosis. ( 1.4 )

1.1Reduction of Elevated Intraocular Pressure (IOP) in Patients With Open-Angle Glaucoma or Ocular Hypertension .

1.2Management of Acute Angle-Closure Glaucoma .

1.3Prevention of Postoperative Elevated IOP Associated With Laser Surgery .

1.4Induction of Miosis .

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Instill one drop in the eye(s) up to four times daily. ( 2 )

2.1Reduction of Elevated IOP in Patients With Open-Angle Glaucoma or Ocular Hypertension One drop of pilocarpine hydrochloride ophthalmic solution 1%, 2%, or 4% should be applied topically in the eye(s) up to four times daily. Pilocarpine-naïve patients should be started on the 1% concentration as higher concentrations are often not tolerated initially. The frequency of instillation and concentration of pilocarpine hydrochloride ophthalmic solution are determined by the severity of the elevated intraocular pressure and miotic response of the patient.

To limit systemic exposure to pilocarpine, patients may be instructed to perform punctal occlusion for 2 minutes after instillation of pilocarpine hydrochloride ophthalmic solution.

2.2Management of Acute Angle-Closure Glaucoma Prior to pilocarpine hydrochloride ophthalmic solution use, treatment with secretory suppressants and hyperosmotic agents may be needed to lower IOP below 50 mmHg and relieve iris ischemia. For initial management of acute angle-closure glaucoma, one drop of pilocarpine hydrochloride ophthalmic solution 1% or 2% may be applied topically in the eye(s) up to three times over a 30-minute period. If laser iridoplasty or iridomy is used to break the attack, one drop of pilocarpine hydrochloride ophthalmic solution 4% should be administered prior to the procedure.

Following laser iridoplasty, one drop of pilocarpine hydrochloride ophthalmic solution 1% should be administered four times daily until an iridotomy can be performed.

2.3Prevention of Postoperative Elevated IOP Associated With Laser Surgery One drop of pilocarpine hydrochloride ophthalmic solution 1%, 2%, or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s) 15 to 60 minutes prior to surgery.

2.4Induction of Miosis One drop of pilocarpine hydrochloride ophthalmic solution 1%, 2%, or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s).

2.5Use With Other Topical Ophthalmic Medications Pilocarpine hydrochloride ophthalmic solution may be used in combination with beta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

2.6Use in Pediatric Patients In children under 2 years of age, one drop of pilocarpine hydrochloride ophthalmic solution 1% should be applied topically in the eye(s) three times daily. Children 2 years of age and over should be dosed as for adults. For the induction of miosis prior to goniotomy or trabeculotomy in children, one drop of pilocarpine hydrochloride ophthalmic solution 1% or 2% should be applied topically in the eye 15 to 60 minutes prior to surgery.

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Bottle filled with 15 mL of 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL) pilocarpine hydrochloride sterile ophthalmic solution. • Solution containing 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL) pilocarpine hydrochloride. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Poor Illumination : Exercise caution in night driving and other hazardous occupations in poor illumination. ( 5.1 ) • Preexisting Retinal Disease : Rare cases of retinal detachment have been reported; a thorough examination of the retina, including funduscopy is advised in all patients prior to the initiation of therapy. ( 5.2 ) • Iritis : Caution is advised in patients with iritis.

( 5.3 ) • Congenital Glaucoma : Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. ( 5.4 )

5.1Poor Illumination Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear.

5.2Preexisting Retinal Disease As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with preexisting retinal disease; therefore, a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy.

5.3Iritis Pilocarpine hydrochloride ophthalmic solution is not recommended to be used when iritis is present.

5.4Primary Congenital Glaucoma Caution is advised when using pilocarpine hydrochloride ophthalmic solution in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. In addition, the use of pilocarpine hydrochloride ophthalmic solution is not recommended in pediatric patients diagnosed with glaucoma secondary to anterior segment dysgenesis or uveitis (especially if uveitis is active).

5.5Contact Lens Wear Contact lens wearers should be advised to remove their lenses prior to the instillation of pilocarpine hydrochloride ophthalmic solution and to wait 10 minutes after dosing before reinserting their contact lenses.

🤒 Adverse Reactions 212 words ▾

6 ADVERSE REACTIONS Most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment. ( 6.1 ) 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 .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension. In the four clinical trials, patients were treated with pilocarpine hydrochloride ophthalmic solution 2%, two to four times daily or with pilocarpine 1%, 1.75%, or 2% in fixed combination with betaxolol 0.25%, two or three times daily.

The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/brow ache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain. The adverse reaction profile reported for the use of pilocarpine hydrochloride ophthalmic solution in pediatric patients is comparable to that seen in adult patients.

👥 Use in Specific Populations 128 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Animal reproduction studies have not been conducted with pilocarpine hydrochloride. It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed.

8.3Nursing 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 pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.

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

🤰 Pregnancy 50 words ▾

8.1Pregnancy Animal reproduction studies have not been conducted with pilocarpine hydrochloride. It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use Safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.

🧓 Geriatric Use 18 words ▾

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

🆘 Overdosage 81 words ▾

10 OVERDOSAGE Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity following the suggested dosage and administration. Overdosage can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration.

For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.

🧬 Clinical Pharmacology 184 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pilocarpine hydrochloride is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic receptors and smooth muscle such as the iris and secretory glands. Pilocarpine contracts the ciliary muscle, causing increased tension on the scleral spur and opening of the trabecular meshwork spaces to facilitate outflow of aqueous humor. Outflow resistance is reduced, lowering IOP.

Pilocarpine also produces miosis through contraction of the iris sphincter muscle. Miosis relieves appositional angle narrowing and closure, which lowers IOP in certain types of angle-closure glaucoma.

12.3Pharmacokinetics Systemic exposure to pilocarpine was evaluated in 14 healthy subjects administered 2 drops of pilocarpine hydrochloride ophthalmic solution 4% to both eyes four times daily for eight days. A comparison of C max values on Days 5 and 8 indicated that pilocarpine concentrations in plasma reached steady-state following topical administration of pilocarpine hydrochloride ophthalmic solution 4%. The mean (SD) C max and AUC 0-last values on Day 8 were 3.7 (3.2) ng/mL and 7.7 (8.4) ng×hour/mL, respectively.

The T max values on Day 8 ranged from 0.5 to 1 hour.

🧬 Mechanism of Action 89 words ▾

12.1Mechanism of Action Pilocarpine hydrochloride is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic receptors and smooth muscle such as the iris and secretory glands. Pilocarpine contracts the ciliary muscle, causing increased tension on the scleral spur and opening of the trabecular meshwork spaces to facilitate outflow of aqueous humor. Outflow resistance is reduced, lowering IOP.

Pilocarpine also produces miosis through contraction of the iris sphincter muscle. Miosis relieves appositional angle narrowing and closure, which lowers IOP in certain types of angle-closure glaucoma.

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pilocarpine hydrochloride ophthalmic solution 1%, 2%, and 4% is supplied sterile in natural low density polyethylene plastic ophthalmic dispensers and green low density polyethylene tips with green polypropylene caps. 15 mL in 15 mL bottles 1%: NDC 61314-203-15 2%: NDC 61314-204-15 4%: NDC 61314-206-15 STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

📋 Description 134 words ▾

11 DESCRIPTION Pilocarpine hydrochloride ophthalmic solution is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established name: pilocarpine hydrochloride Chemical name: 2(3 H )-furanone, 3-ethyldihydro-4-[(1-methyl-1 H -imidazol-5-yl)-methyl]- monohydrochloride, (3S- cis )-. Molecular Formula: C 11 H 16 N 2 O 2 • HCl; Molecular Weight: 244.72 g/mol.

Each mL of contains: Active: pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 2910, boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust pH); purified water.

Pilocarpine hydrochloride ophthalmic solution has a pH of 3.5 to 5.5 and an osmolality of 290 to 350 mOsm/kg (1% and 2% products) and 550 to 600 mOsm/kg (4% product). Chemical Diagram

💬 Information for Patients 175 words ▾

17 PATIENT COUNSELING INFORMATION Avoiding Contamination of the Product Do not touch dropper tip to any surface, as this may contaminate the contents. Night Driving Caution is advised with night driving and when hazardous activities are undertaken in poor illumination. Accommodative Spasm Pilocarpine hydrochloride ophthalmic solution may cause problems when changing focus between near objects and distant objects.

Do not drive or use machinery if vision is not clear. Contact Lens Wear Contact lens should be removed prior to the instillation of pilocarpine hydrochloride ophthalmic solution. Wait 10 minutes after dosing before reinserting contact lenses.

Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Systemic Exposure To limit exposure to pilocarpine to the eye alone, close eyes gently and apply pressure with finger to the corner of eye by the nose for 2 minutes after instillation of pilocarpine hydrochloride ophthalmic solution. update to Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc.

Princeton, NJ 08540 T2020-98 300072245-0825

🍼 Nursing Mothers 38 words ▾

8.3Nursing 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 pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman.

🧬 Pharmacokinetics 92 words ▾

12.3Pharmacokinetics Systemic exposure to pilocarpine was evaluated in 14 healthy subjects administered 2 drops of pilocarpine hydrochloride ophthalmic solution 4% to both eyes four times daily for eight days. A comparison of C max values on Days 5 and 8 indicated that pilocarpine concentrations in plasma reached steady-state following topical administration of pilocarpine hydrochloride ophthalmic solution 4%. The mean (SD) C max and AUC 0-last values on Day 8 were 3.7 (3.2) ng/mL and 7.7 (8.4) ng×hour/mL, respectively.

The T max values on Day 8 ranged from 0.5 to 1 hour.

🔬 Clinical Studies 54 words ▾

14 CLINICAL STUDIES In clinical trials reported in the medical literature, pilocarpine ophthalmic solution reduced IOP by 3-7 mmHg in patients with open-angle glaucoma. Pilocarpine ophthalmic solution has also been shown to be effective in the induction of miosis, in the prevention of postoperative elevated IOP, and in the management of acute angle-closure glaucoma.

🧪 Nonclinical Toxicology 25 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 22 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

📄 Package Label / Principal Display Panel 45 words ▾

PRINCIPAL DISPLAY PANEL NDC 61314-203-15 Pilocarpine Hydrochloride Ophthalmic Solution 1% Rx only STERILE 15 mL SANDOZ NDC 61314-204-15 Pilocarpine Hydrochloride Ophthalmic Solution 2% Rx only STERILE 15 mL SANDOZ NDC 61314-206-15 Pilocarpine Hydrochloride Ophthalmic Solution 4% Rx only STERILE 15 mL SANDOZ onepercentcarton 2percentcarton 4percentcarton

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
309
Units reimbursed last 4 qtrs
4.7K
Gross reimbursed last 4 qtrs
$20.6K
Avg / prescription
$66.58
Avg / unit
$4.3401
Latest quarter Q1 2026
99Rx
Medicaid pays / mL
$4.3401
gross reimbursed
vs
NADAC / mL
$2.8144
acquisition cost
=
Spread
+$1.5257
+54% 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 ⓘ
78% FFS 22% MCO
Fee-for-service · 241 Rx Managed care · 68 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: 2,850 units · 14.6 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: 870 units · 2.2 per 100k residents 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
2.214.6
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 14.6 /100k
2 California 2.2 /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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pilocarpine Hydrochloride — the ingredient across all brands.

Top reported reactions

Headache420
Nausea210
Vision Blurred209
Visual Impairment203
Pain197
Fatigue184
Eye Pain164

Age at onset

Adolescent2
Adult227
Elderly223

Reporter sex

0 reports
Male · 23%
Female · 77%
Unknown · 0%

Serious outcomes

Hospitalization679
Death98
Life-threatening58
Disabling58
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 899 129
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 61314-0203-15 · Sandoz 61314-0206-15 · 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.