Pilocarpine Hydrochloride 40 mg/mL Solution/ Drops — NDC 70069-201-01 (Billing 70069-0201-01)
This is a package of Pilocarpine Hydrochloride 40 mg/mL Solution/ Drops from Somerset Therapeutics, LLC, marketed since Nov 2019 and currently FDA-listed; retail pharmacies pay about $3.38 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70069-201-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70069 labeler · 201 product · 01 package
- Package marketed since
- Nov 25, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0370069191019, 0370069201015, 0370069181010
- Medicaid fills, this package
- 124 prescriptions in the last four reported quarters
- FDA record last changed
- Sep 3, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007826
- GCN: 32752
- GPI-14 (Medi-Span): 86501030102030
- HICL (First Databank): 005198
- AHFS class code: 12:04.00.00
- RxCUI (RxNorm): 1000647
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cholinergic Receptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Pilocarpine ophthalmic is used to treat glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) and ocular hypertension (a condition which causes increased pressure in the eye). Pilocarpine ophthalmic is also used to prevent or reduce increased pressure in the eye during and after certain types of laser eye surgery. It is also used during an eye exam to constrict (close) the pupil (the black part of the eye through which you see). Pilocarpine ophthalmic (Vuity, Qlosi) is used to treat presbyopia (a condition in which the lens of the eye loses its abilit...
Read the full MedlinePlus article ↗- 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...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.376 | $50.64 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.97 | $59.58 / 15 ml |
| Medicare drug plans payPart D · Q2 2026 | $4.37 | $65.61 / 15 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70069-0201-01 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE | 2019-11-25 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pilocarpine Hydrochloride 40 mg/mL 61314-0206-15 | Sandoz | 1 bottle | $3.376 | AT | Availability likely | — |
| Pilocarpine Hydrochloride 40 mg/mL 69238-1747-08 | Amneal | 1 bottle | $3.376 | AT | Availability likely | — |
| Pilocarpine Hydrochloride 40 mg/mLthis 70069-0201-01 | Somerset | 1 bottle | $3.376 | AT | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Somerset Therapeutics, LLC labeler code 70069
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- Pilocarpine Hydrochloride 20 mg/mL Solution/ Drops NDC 70069-191-01
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- BRIMONIDINE TARTRATE 2 mg/mL Solution/ Drops NDC 70069-231-01
- BRIMONIDINE TARTRATE 2 mg/mL Solution/ Drops NDC 70069-232-01
- BRIMONIDINE TARTRATE 2 mg/mL Solution/ Drops NDC 70069-233-01
- Timolol Maleate 2.5 mg/mL Solution, Gel Forming / Drops NDC 70069-241-01
- Timolol Maleate 5 mg/mL Solution, Gel Forming / Drops NDC 70069-251-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Pilocarpine hydrochloride ophthalmic solution, is indicated for the: Pilocarpine hydrochloride ophthalmic solution, USP 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
1.2 Management of Acute Angle-Closure Glaucoma
1.3 Prevention of Postoperative Elevated IOP Associated with Laser Surgery
1.4 Induction of Miosis
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop in the eye(s) up to four times daily (2).
2.1Reduction of Elevated Intraocular Pressure (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 (5) 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 ▾
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 ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Poor illumination: Exercise caution in night driving and other hazardous occupations in poor illumination (5.1). Pre-existing 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.
5.2Pre-existing Retinal Disease As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with pre-existing 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 intraocular pressure (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 ▾
6 ADVERSE REACTIONS Clinical Studies 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/browache, 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. 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 Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy. Category C. 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.
🆘 Overdosage ▾
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 ▾
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 intraocular pressure (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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Pilocarpine hydrochloride ophthalmic solution USP, 1%, 2% and 4% is clear colorless solution supplied sterile in natural LDPE bottles plugged with natural LDPE nozzle and green coloured HDPE cap. 15 mL in 15 mL bottles 1%: NDC 70069- 181 -01 2%: NDC 70069- 191 -01 4%: NDC 70069- 201 -01 STORAGE: Store between 15º to 25ºC (59º to 77ºF) and protect from freezing; [see USP Controlled Room Temperature].
📋 Description ▾
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: Molecular 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.
Each mL of pilocarpine hydrochloride ophthalmic solution 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); water for injection.
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 500 to 600 mOsm/kg (4% product). Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Avoiding Contamination of the Product Do not touch dropper tip to any surface, as this may contaminate the contents.
17.2Night Driving Caution is advised with night driving and when hazardous activities are undertaken in poor illumination.
17.3Accommodative 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.
17.4Contact 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.
17.5Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.
17.6Systemic 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. Rx only Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-PIL/P/02 1201313
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In clinical trials reported in the medical literature, pilocarpine ophthalmic solution reduced intraocular pressure (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 ▾
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.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label: Pilocarpine hydrochloride ophthalmic solution USP, 1% Carton Label: Pilocarpine hydrochloride ophthalmic solution USP, 1% Container Label: Pilocarpine hydrochloride ophthalmic solution USP, 2% Carton Label: Pilocarpine hydrochloride ophthalmic solution USP, 2% Container Label: Pilocarpine hydrochloride ophthalmic solution USP, 4 % Carton Label: Pilocarpine hydrochloride ophthalmic solution USP, 4 % Container 1% Carton 1% Container 2% Carton 2% Container 4% Carton 4%