Timoptic in Ocudose Timolol Maleate 5 mg/mL Solution — NDC 69918-601-60 (Billing 69918-0601-60)
This is a package of Timoptic in Ocudose Timolol Maleate 5 mg/mL Solution from Nordic Pharma, Inc., marketed since Feb 2022 and currently FDA-listed; retail pharmacies pay about $1.26 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 69918-601-60 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69918 labeler · 601 product · 60 package
- Package marketed since
- Feb 26, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6991860160 1
- Medicaid fills, this package
- 233 prescriptions in the last four reported quarters
- FDA record last changed
- Aug 13, 2026
Other active recalls for Timolol Maleate (different manufacturers) — 6 · tap to view
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): 030007
- GCN: 32826
- HICL (First Databank): 036505
- AHFS class code: 52:40.08.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Ophthalmic timolol is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Timolol is in a class of medications called beta-blockers. It works by decreasing the pressure in the eye.
Read the full MedlinePlus article ↗- It depends on the form. The eye drops lower high pressure in the eye from ocular hypertension or open-angle glaucoma. The tablets treat high blood pressure, lower the risk of death...
- Put the drop in the affected eye as directed, usually once or twice a day depending on your product. If yours is a gel-forming type, shake the closed bottle once first. Wait at lea...
- Burning or stinging right after the drops go in is the most common. Blurred vision, redness, itching and headache can also happen. Call your doctor if you notice wheezing, a very s...
- If your drops contain benzalkonium chloride, soft lenses can absorb it. Take your lenses out before using the drops and wait 15 minutes before putting them back in.
Patient education
Supplement & herbal interactions
Timolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.256 | $753.30 / 600 containers |
| Medicaid paysCMS SDUD · 12 mo | $3.98 | $2,388.48 / 600 containers |
| Medicare drug plans payPart D · Q2 2026 | $4.84 | $2,906.94 / 600 containers |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- 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 |
|---|---|---|---|---|
| 69918-0601-60 You're viewing this Main listing | 60 POUCH in 1 CARTON / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER | 2022-02-26 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| timolol maleate 5 mg/mL 70756-0657-30 | Lifestar | 1 bottle | $0.720 | AT1 | Availability likely | save 43% |
| Timolol Maleate 5 mg/mL 64980-0514-01 | Rising | 1 bottle | $0.720 | AT1 | Availability likely | save 43% |
| Timolol maleate 5 mg/mL 70069-0707-01 | Somerset | 1 bottle | $0.720 | AT1 | Availability likely | save 43% |
| Timolol Maleate 5 mg/mL 65145-0153-01 | Caplin | 1 bottle | $0.720 | AT1 | Availability likely | save 43% |
| Timolol maleate 5 mg/mL 70069-0708-01 | Somerset | 1 bottle | $0.774 | AT1 | Availability likely | save 38% |
| Timolol Maleate 5 mg/mL 65145-0154-01 | Caplin | 1 bottle | $0.774 | AT1 | Availability likely | save 38% |
| timolol maleate 5 mg/mL 70756-0656-15 | Lifestar | 1 bottle | $1.046 | AT1 | Availability likely | save 17% |
| Timolol Maleate 5 mg/mL 65145-0152-01 | Caplin | 1 bottle | $1.046 | AT1 | Availability likely | save 17% |
| Timolol maleate 5 mg/mL 70069-0706-01 | Somerset | 1 bottle | $1.046 | AT1 | Availability likely | save 17% |
| Timolol Maleate 5 mg/mL 61314-0227-05 | Sandoz | 5 ml | $1.046 | AT1 | Availability likely | save 17% |
| Timolol Maleate 5 mg/mL 69315-0325-05 | Leading | 5 ml | $1.046 | AT1 | Availability likely | save 17% |
| Timolol Maleate 5 mg/mL 60758-0801-05 | Pacific | 1 bottle | $1.046 | AT1 | Availability likely | save 17% |
| Timolol Maleate 5 mg/mL 82260-0813-05 | Bausch | 1 bottle | $1.046 | AT1 | Availability likely | save 17% |
| timolol maleate 5 mg/mL 72603-0540-01 | NorthStar | 1 bottle | $1.046 | AT1 | Availability likely | save 17% |
| Timolol maleate 6.8 mg/mL 72485-0602-60 | Armas | 6 pouches | $1.241 | AT3 | Availability likely | save 1% |
| Timolol Maleate 6.8 mg/mL 42571-0398-71 | Micro | 6 pouches | $1.255 | AT3 | Availability likely | — |
| Timolol Maleate 6.8 mg/mL 50742-0288-60 | Ingenus | 15 pouches | $1.255 | AT3 | Availability likely | — |
| Timoptic in Ocudose 5 mg/mLthis 69918-0601-60 | Nordic | 60 pouches | $1.255 | AT3 | Availability likely | — |
| Timolol Maleate 6.8 mg/mL 82260-0496-05 | Bausch | 6 pouches | $1.255 | AT3 | Availability likely | — |
| Timolol Maleate 5 mg/mL 82260-0819-05 | Bausch | 1 bottle | $8.302 | AB | Availability likely | +561% |
| Timolol Maleate 5 mg/mL 25021-0009-05 | Sagent | 1 bottle | $8.302 | AB | Availability likely | +561% |
| Timolol GFS 5 mg/mL 61314-0225-05 | Sandoz | 5 ml | $8.302 | AB | Availability likely | +561% |
| Timolol Maleate 5 mg/mL 82260-0045-05 | Bausch | 1 bottle | $22.290 | AT2 | Availability likely | +1675% |
| Timolol Maleate 5 mg/mL 68682-0045-25 | Oceanside | 1 bottle | $26.378 | AT2 | Discontinued | +2001% |
| Istalol 5 mg/mL 24208-0004-01 | Bausch | 1 bottle | $79.763 | AT2 | Availability likely | +6253% |
| Timoptic in Ocudose 6.8 mg/mL 24208-0499-00 | Bausch | 1 pouch | — | AT3 | FDA listed | — |
| Timoptic 5 mg/mL 24208-0813-05 | Bausch | 1 bottle | — | AT1 | FDA listed | — |
| Timoptic-XE 5 mg/mL 24208-0816-05 | Bausch | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-7837-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-3441-00 | A-S | 10 ml | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 59651-0313-05 | Aurobindo | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-5769-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
| timolol maleate 5 mg/mL 81469-0210-05 | First | 1 bottle | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 70069-0251-01 | Somerset | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-1852-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 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
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 Timolol 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.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
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UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
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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.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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 Nordic Pharma, Inc. labeler code 69918
- Lamotrigine 25 mg Tablet NDC 69918-350-30
- Lamotrigine 50 mg Tablet NDC 69918-360-30
- Lamotrigine 100 mg Tablet NDC 69918-370-30
- Lamotrigine 200 mg Tablet NDC 69918-380-30
- neomycin sulfate, polymyxin b sulfate and dexamethasone 3.5 mg/mL; 10000 [USP'U]/mL; 1 mg/mL Suspension NDC 69918-515-05
- Mesalamine Rectal 1000 mg Suppository NDC 69918-560-30
- Succinylcholine Chloride 20 mg/mL Injection, Solution NDC 69918-700-10
- ARSENIC TRIOXIDE 1 mg/mL Injection, Solution NDC 69918-720-02
- Isoproterenol Hydrochloride .2 mg/mL Injection, Solution NDC 69918-731-10
- Isoproterenol Hydrochloride .2 mg/mL Injection, Solution NDC 69918-735-10
- Desmopressin Acetate 4 ug/mL Solution NDC 69918-899-01
- Desmopressin Acetate 4 ug/mL Solution NDC 69918-901-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is a sterile solution that does not contain a preservative. The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be guaranteed after the individual unit is opened, the remaining contents should be discarded immediately after administration.
Preservative-free timolol maleate ophthalmic solution in the unit dose vial is available in concentrations of 0.25% and 0.5%. The usual starting dose is one drop of 0.25% preservative-free timolol maleate ophthalmic solution in the unit dose vial in the affected eye(s) administered twice a day. Apply enough gentle pressure on the individual vial to obtain a single drop of solution.
If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) administered twice a day. Since in some patients the pressure-lowering response to preservative-free timolol maleate ophthalmic solution in the unit dose vial may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with preservative-free timolol maleate ophthalmic solution in the unit dose vial. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s).
Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day. Dosages above one drop of 0.5% timolol maleate ophthalmic solution twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient’s intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted taking into consideration that the preparation(s) used concomitantly may contain one or more preservatives.
The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS , Drug Interactions, Beta-adrenergic blocking agents .)
⛔ Contraindications ▾
CONTRAINDICATIONS Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS ); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS ); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
⚠️ Warnings ▾
WARNINGS As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate USP (see CONTRAINDICATIONS ).
Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In Patients without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, preservative-free timolol maleate ophthalmic solution USP in unit dose vial should be discontinued.
Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which timolol maleate ophthalmic solution USP is contraindicated [see CONTRAINDICATIONS ]) should, in general, not receive beta-blockers, including preservative-free timolol maleate ophthalmic solution USP in the unit dose vial. Major Surgery The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial.
Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia.
Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.
Diabetes Mellitus Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia. Thyrotoxicosis Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.
Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate USP formulations: BODY AS A WHOLE Headache, asthenia/fatigue, and chest pain. CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud’s phenomenon, and cold hands and feet.
DIGESTIVE Nausea, diarrhea, dyspepsia, anorexia, and dry mouth. IMMUNOLOGIC Systemic lupus erythematosus. NERVOUS SYSTEM/PSYCHIATRIC Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.
SKIN Alopecia and psoriasiform rash or exacerbation of psoriasis. HYPERSENSITIVITY Signs and symptoms of systemic allergic reactions including anaphylaxis, angioedema, urticaria, and localized and generalized rash. RESPIRATORY Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.
ENDOCRINE Masked symptoms of hypoglycemia in diabetic patients (see WARNINGS ). SPECIAL SENSES Signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery (see PRECAUTIONS, General ); and tinnitus. UROGENITAL Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie’s disease.
The following additional adverse effects have been reported in clinical experience with ORAL timolol maleate USP or other ORAL beta blocking agents, and may be considered potential effects of ophthalmic timolol maleate USP: Allergic : Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole : Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular : Worsening of arterial insufficiency, vasodilatation; Digestive : Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic : Nonthrombocytopenic purpura; thrombocytopenic purpura; agranulocytosis; Endocrine : Hyperglycemia, hypoglycemia; Skin : Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal : Arthralgia; Nervous System/Psychiatric : Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory : Rales, bronchial obstruction; Urogenital : Urination difficulties.
To report SUSPECTED ADVERSE REACTIONS, contact Nordic Pharma, Inc. at 1-844-267-4641 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
Drug Interactions Although timolol maleate ophthalmic solution USP used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with timolol maleate ophthalmic solution USP and epinephrine has been reported occasionally. Beta-adrenergic blocking agents : Patients who are receiving a beta-adrenergic blocking agent orally and preservative-free timolol maleate ophthalmic solution USP in the unit dose vial should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure.
The concomitant use of two topical beta-adrenergic blocking agents is not recommended. Calcium antagonists : Caution should be used in the coadministration of beta-adrenergic blocking agents, such as preservative-free timolol maleate ophthalmic solution USP in the unit dose vial, and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided.
Catecholamine-depleting drugs : Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension. Digitalis and calcium antagonists : The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
CYP2D6 inhibitors : Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol. Clonidine : Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. There have been no reports of exacerbation of rebound hypertension with ophthalmic timolol maleate.
Injectable epinephrine : (See PRECAUTIONS, General, Anaphylaxis )
🤰 Pregnancy ▾
Pregnancy : Teratogenic Effects : Teratogenicity studies with timolol in mice, rats and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions.
Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. There are no adequate and well-controlled studies in pregnant women. Preservative-free timolol maleate ophthalmic solution USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of timolol maleate ophthalmic solution USP have been established when administered in pediatric patients aged 2 years and older. Use of timolol maleate ophthalmic solution USP in these children is supported by evidence from adequate and well- controlled studies in children and adults. Safety and efficacy in pediatric patients below the age of 2 years have not been established.
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE There have been reports of inadvertent overdosage with timolol maleate ophthalmic solution USP resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest (see also ADVERSE REACTIONS ). Overdosage has been reported with timolol maleate USP tablets. A 30 year old female ingested 650 mg of timolol maleate USP tablets (maximum recommended oral daily dose is 60 mg) and experienced second and third degree heart block.
She recovered without treatment but approximately two months later developed irregular heartbeat, hypertension, dizziness, tinnitus, faintness, increased pulse rate, and borderline first degree heart block. An in vitro hemodialysis study, using 14 C timolol added to human plasma or whole blood, showed that timolol was readily dialyzed from these fluids; however, a study of patients with renal failure showed that timolol did not dialyze readily.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Timolol maleate USP is a beta 1 and beta 2 (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor blockade may inhibit the stimulatory effect of the sympathetic nervous system necessary to maintain adequate cardiac function.
Beta-adrenergic receptor blockade in the bronchi and bronchioles results in increased airway resistance from unopposed parasympathetic activity. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous. Timolol maleate ophthalmic solution USP, when applied topically on the eye, has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma.
Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. The onset of reduction in intraocular pressure following administration of timolol maleate ophthalmic solution USP can usually be detected within one-half hour after a single dose.
The maximum effect usually occurs in one to two hours and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose. Repeated observations over a period of one year indicate that the intraocular pressure-lowering effect of timolol maleate ophthalmic solution USP is well maintained. The precise mechanism of the ocular hypotensive action of timolol maleate ophthalmic solution USP is not clearly established at this time.
Tonography and fluorophotometry studies in man suggest that its predominant action may be related to reduced aqueous formation. However, in some studies a slight increase in outflow facility was also observed. Pharmacokinetics In a study of plasma drug concentration in six subjects, the systemic exposure to timolol was determined following twice daily administration of timolol maleate ophthalmic solution USP 0.5%.
The mean peak plasma concentration following morning dosing was 0.46 ng/mL and following afternoon dosing was 0.35 ng/mL. Clinical Studies In controlled multiclinic studies in patients with untreated intraocular pressures of 22 mmHg or greater, timolol maleate ophthalmic solution USP 0.25% or 0.5% administered twice a day produced a greater reduction in intraocular pressure than 1, 2, 3, or 4% pilocarpine solution administered four times a day or 0.5, 1, or 2% epinephrine hydrochloride solution administered twice a day.
In these studies, timolol maleate ophthalmic solution USP was generally well tolerated and produced fewer and less severe side effects than either pilocarpine or epinephrine. A slight reduction of resting heart rate in some patients receiving timolol maleate ophthalmic solution USP (mean reduction 2.9 beats/minute standard deviation 10.2) was observed.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Preservative-free Timolol Maleate Ophthalmic Solution USP is a clear, colorless to light yellow solution. Preservative-free Timolol Maleate Ophthalmic Solution USP, 0.25% timolol equivalent, is supplied in a clear low density polyethylene vial. Each individual unit contains 0.3 mL of solution, and is available in 2 blocks of 5 vials in a sealed aluminum pouch; six pouches per carton.
NDC 69918-602-60; 0.3 mL Single-dose vials in a carton of 60. Preservative-free Timolol Maleate Ophthalmic Solution, 0.5% timolol equivalent, is supplied in a clear low density polyethylene vial. Each individual unit contains 0.3 mL of solution, and is available in 2 blocks of 5 vials in a sealed aluminum pouch; six pouches per carton.
NDC 69918-601-60; 0.3 mL Single-dose vials in a carton of 60. Storage Store at room temperature, 15 to 30°C (59 to 86°F). Protect from freezing.
Protect from light. Because evaporation can occur through the unprotected polyethylene unit dose vial and prolonged exposure to direct light can modify the product, the unit dose vial should be kept in the protective foil overwrap and used within one month after the foil package has been opened. Keep out of Reach of Children.
Manufactured for: Nordic Pharma, Inc. Berwyn, PA 19312 www.nordicpharmausa.com The Nordic Pharma Logo is a trademark of Nordic Group B.V. Manufactured by: Rommelag CDMO GmbH, Bahnhofstrasse 18, 74429 Sulzbach-Laufen, Germany Origin Germany Rev.
02/2026 006-00423 label1
📋 Description ▾
DESCRIPTION Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer.
The optical rotation of timolol maleate is: [α] 25° 405 nm in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°) Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 and its structural formula is: Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature.
Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate).
The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection. formula
💬 Information for Patients ▾
Information for Patients Patients should be instructed about the use of preservative-free timolol maleate ophthalmic solution USP in the unit dose vial. Since sterility cannot be maintained after the individual unit is opened, patients should be instructed to use the product immediately after opening, and to discard the individual unit and any remaining contents immediately after use. Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product.
(See CONTRAINDICATIONS .)
⚠️ Precautions ▾
PRECAUTIONS General Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with preservative-free timolol maleate ophthalmic solution USP in the unit dose vial, alternative therapy should be considered. Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g. timolol).
Angle-closure glaucoma : In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil. Timolol maleate USP has little or no effect on the pupil.
Timolol maleate ophthalmic solution USP in the unit dose vial should not be used alone in the treatment of angle-closure glaucoma. Anaphylaxis : While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
Muscle Weakness : Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms. Information for Patients Patients should be instructed about the use of preservative-free timolol maleate ophthalmic solution USP in the unit dose vial.
Since sterility cannot be maintained after the individual unit is opened, patients should be instructed to use the product immediately after opening, and to discard the individual unit and any remaining contents immediately after use. Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product. (See CONTRAINDICATIONS .) Drug Interactions Although timolol maleate ophthalmic solution USP used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with timolol maleate ophthalmic solution USP and epinephrine has been reported occasionally.
Beta-adrenergic blocking agents : Patients who are receiving a beta-adrenergic blocking agent orally and preservative-free timolol maleate ophthalmic solution USP in the unit dose vial should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. Calcium antagonists : Caution should be used in the coadministration of beta-adrenergic blocking agents, such as preservative-free timolol maleate ophthalmic solution USP in the unit dose vial, and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension.
In patients with impaired cardiac function, coadministration should be avoided. Catecholamine-depleting drugs : Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension. Digitalis and calcium antagonists : The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
CYP2D6 inhibitors : Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Timolol maleate USP has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from timolol in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility In a two-year study of timolol maleate USP administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day (approximately 42,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Similar differences were not observed in rats administered oral doses equivalent to approximately 14,000 times the maximum recommended human ophthalmic dose.
In a lifetime oral study in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose), but not at 5 or 50 mg/kg/day (approximately 700 or 7,000 times, respectively, the systemic exposure following the maximum recommended human ophthalmic dose). In a subsequent study in female mice, in which post-mortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumors was again observed at 500 mg/kg/day.
The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumors has been established in humans. Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate USP (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.
Timolol maleate USP was devoid of mutagenic potential when tested in vivo (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg/kg) and in vitro in a neoplastic cell transformation assay (up to 100 mcg/mL). In Ames tests the highest concentrations of timolol employed, 5,000 or 10,000 mcg/plate, were associated with statistically significant elevations of revertants observed with tester strain TA100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2.
A ratio of 2 is usually considered the criterion for a positive Ames test. Reproduction and fertility studies in rats demonstrated no adverse effect on male or female fertility at doses up to 21,000 times the systemic exposure following the maximum recommended human ophthalmic dose.
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 69918 -601- 60 Rx only Timolol Maleate Ophthalmic Solution, USP 0.5% * For Topical Application In The Eye Preservative-Free Sterile Ophthalmic Solution Keep out of reach of children. 60 x 0.3 mL Single-dose Vials PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 69918 -601- 60 Rx only Timolol Maleate Ophthalmic Solution, USP 0.5% * For Topical Application In The Eye Preservative-Free Sterile Ophthalmic Solution Keep out of reach of children. 10 x 0.3 mL Single-dose Vials timo carton .25 timo Foil .25