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Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL Solution/ Drops — NDC 68083-0624-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL Solution/ Drops — NDC 68083-624-01 (Billing 68083-0624-01)

by Gland Pharma Limited · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL Solution/ Drops from Gland Pharma Limited, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 68083-0624-01
🏷️ FDA NDC (as labeled) 68083-624-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Brimonidine Tartrate And Timolol Maleate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 5, 2026 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0407-2026
Class II · Sep 5, 2025 — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns (Apotex Corp.) · FDA recall D-0676-2025
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0496-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68083-624-01
Product NDC 68083-624
11-digit billing NDC 68083062401
RxCUI 861635
UNII P8Y54F701R, 4S9CL2DY2H
Application # ANDA219166
SPL Set ID 038cf2ba-ad08-4981-a3cc-bff0e4ba5dfb
Established class (EPC) alpha-Adrenergic Agonist; beta-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-11
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BRIMONIDINE TARTRATE; TIMOLOL MALEATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 861635
Why two NDCs? The FDA registers this code as 68083-624-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68083-0624-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, non-selective, Beta blocking agents
How it works Adrenergic beta-Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) or ocular hypertension (increased pressure in the eyes). Brimonidine is in a class of drugs called alpha adrenergic agonists. Brimonidine works by decreasing the amount of fluid in the eyes.

Read the full MedlinePlus article ↗

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
68083-0624-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 2026-06-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0164-01 Caplin 1 bottle $1.972 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0653-01 Somerset 1 bottle $1.972 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 00781-7186-70 Sandoz 10 ml $2.151 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0163-01 Caplin 1 bottle $2.151 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL 68462-0281-32 Glenmark 1 bottle $2.151 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0652-01 Somerset 1 bottle $2.151 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 00832-1425-05 Upsher-Smith 1 bottle $2.717 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 60505-0589-01 Apotex 1 bottle $2.717 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 62332-0706-05 Alembic 1 bottle $2.717 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 65145-0162-01 Caplin 1 bottle $2.717 AB Availability likely —
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 69315-0330-05 Leading 1 bottle $2.717 AB Availability likely —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 70069-0651-01 Somerset 1 bottle $2.717 AB Availability likely —
Brimonidine Tartrate And Timolol Maleate 2 mg/mL; 5 mg/mL 71921-0188-05 Florida 1 bottle $2.717 AB Availability likely —
Brimonidine tartrate and Timolol maleate 2 mg/mL; 5 mg/mL 72603-0931-05 NorthStar 1 bottle $2.717 AB Availability likely —
Combigan 2 mg/mL; 5 mg/mL 00023-9211-03 Allergan, 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol Maleate 2 mg/mL; 5 mg/mL 46708-0706-05 Alembic 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mLthis 68083-0624-01 Gland 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0625-01 Gland 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 68083-0664-01 Gland 1 bottle — AB FDA listed —
Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL 72485-0634-05 ARMAS 1 bottle — AB FDA listed —
Brimonidine Tartrate and Timolol maleate Ophthalmic Solution 2 mg/mL; 5 mg/mL 73043-0029-01 Devatis 1 bottle — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 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.
  • UNII 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • 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.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGland Pharma Limited
Application holderGLAND PHARMA LTD
FDA applicationANDA219166 (ANDA)
Labeler code68083
First marketedJun 2026
Product typeHuman Prescription Drug
Portfolio262 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 173 words ▾

1 INDICATIONS AND USAGE Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is a combination of brimonidine tartrate, an alpha-adrenergic receptor agonist, and timolol maleate, a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day.

⏱️ Dosage and Administration 54 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. One drop in the affected eye(s), twice daily approximately 12 hours apart.

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing 0.2% brimonidine tartrate and 0.5% timolol (6.834 mg/mL timolol maleate). Ophthalmic Solution: 0.2% brimonidine tartrate and 0.5% timolol.

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease. ( 4.1 , 5.1 , 5.3 ) Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock. ( 4.2 , 5.2 ) Neonates and infants (pediatric patients younger than 2 years old). ( 4.3 ) Hypersensitivity to any component of this product. ( 4.4 )

4.1Reactive Airway Disease Including Asthma, COPD Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions ( 5.1 , 5.3 )] .

4.2Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see Warnings and Precautions ( 5.2 )] ; cardiogenic shock.

4.3Neonates and Infants (Pediatric Patients Younger Than 2 Years Old) Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )] .

4.4Hypersensitivity Reactions Local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate/timolol maleate ophthalmic solution. Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Potential for Severe Respiratory or Cardiac Reactions ( 5.1 ) Cardiac Failure ( 5.2 ) Obstructive Pulmonary Disease ( 5.3 ) Potentiation of Vascular Insufficiency ( 5.4 ) Increased Reactivity to Allergens ( 5.5 ) Potentiation of Muscle Weakness ( 5.6 ) Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus ( 5.7 ) Masking of Thyrotoxicosis ( 5.8 ) Ocular Hypersensitivity ( 5.9 )

5.1Potential for Severe Respiratory or Cardiac Reactions Brimonidine tartrate/timolol maleate ophthalmic solution contains timolol maleate; and although administered topically can be absorbed systemically. Therefore, the same types of 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 [see Contraindications ( 4.1 )] .

Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.

5.2Cardiac 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, brimonidine tartrate/timolol maleate ophthalmic solution should be discontinued [see Contraindications ( 4.2 )] .

5.3Obstructive 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 brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated [see Contraindications ( 4.1 )] ) should, in general, not receive beta-blocking agents, including brimonidine tartrate/timolol maleate ophthalmic solution.

5.4Potentiation of Vascular Insufficiency Brimonidine tartrate/timolol maleate ophthalmic solution may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate/timolol maleate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

5.5Increased Reactivity to Allergens 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.

5.6Potentiation of 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.

5.7Masking of Hypoglycemic Symptoms in Patients with 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.

5.8Masking of Thyrotoxicosis Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be ma…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4.4 )] Potential for Severe Respiratory or Cardiac Reactions [see Warnings and Precautions ( 5.1 )] Cardiac Failure [see Warnings and Precautions ( 5.2 )] Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.4 )] Increased Reactivity to Allergens [see Warnings and Precautions ( 5.5 )] Potentiation of Muscle Weakness [see Warnings and Precautions ( 5.6 )] Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.7 )] Masking of Thyrotoxicosis [see Warnings and Precautions ( 5.8 )] Ocular Hypersensitivity [see Warnings and Precautions ( 5.9 )] Contamination of Topical Ophthalmic Products after Use [see Warnings and Precautions ( 5.10 )] Impairment of Beta-adrenergically Mediated Reflexes During Surgery [see Warnings and Precautions ( 5.11 )] Most common adverse reactions occurring in approximately 5% to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 866-770-7144 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. Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution In clinical trials of 12 months duration with brimonidine tartrate/timolol maleate ophthalmic solution, the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.

The following adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depression, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance. Other adverse reactions that have been reported with the individual components are listed below. Brimonidine Tartrate (0.1% - 0.2%) Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival blanching, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), hordeolum, insomnia, keratitis, lid crusting, lid disorder, muscular pain, nasal dryness, ocular allergic reaction, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, superficial punctate keratopathy, tearing, upper respiratory symptoms, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

Timolol (Ocular Administration) Body as a whole : chest pain Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud’s phenomenon, syncope, and worsening of angina pectoris Digestive: anorexia, diarrhea, nausea Immunologic: Systemic lupus erythematosus Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis Hypersensitivity…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ( 7.2 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension.

( 7.3 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ( 7.4 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.5 ) Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

( 7.6 ) CYP2D6 inhibitors may potentiate systemic beta-blockade. ( 7.7 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.8 ) Monoamine oxidase inhibitors may result in increased hypotension.

( 7.9 )

7.1Antihypertensives/Cardiac Glycosides Because brimonidine tartrate/timolol maleate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate/timolol maleate ophthalmic solution is advised.

7.2Beta-adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent either orally or intravenously and brimonidine tartrate/timolol maleate ophthalmic solution 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.

7.3Calcium Antagonists Caution should be used in the co-administration of beta-adrenergic blocking agents, such as brimonidine tartrate/timolol maleate ophthalmic solution, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided.

7.4Catecholamine-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.

7.5CNS Depressants Although specific drug interaction studies have not been conducted with brimonidine tartrate/timolol maleate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.

7.6Digitalis 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.

7.7CYP2D6 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.

7.8Tricyclic Antidepressants Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with brimonidine tartrate/timolol maleate ophthalmic solution in humans can lead to resulting interference with the IOP-lowering effect. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

7.9Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side effect such as hypotension. Caution, however, is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Use with caution in pediatric patients aged 2 years and older. ( 8.4 )

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate/timolol maleate ophthalmic solution in pregnant women. Limited available data from postmarketing safety reports and published literature reviews with brimonidine tartrate/timolol maleate ophthalmic solution use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data) . In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent.

Oral administration of brimonidine tartrate or timolol maleate to pregnant rats and rabbits during organogenesis at dose exposures 580 and 37 times the recommended human ophthalmic dose (RHOD) resulted in no adverse developmental effects (see Data) . Oral administration of timolol maleate to mice, rats, and rabbits during organogenesis at dose exposures up to 4,200 times the RHOD resulted in no evidence of fetal malformations (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by the breastfed infant.

Animal Data Embryo fetal development studies were conducted with oral administration of brimonidine tartrate during organogenesis in rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18). No adverse developmental effects were observed in rats up to 2.5 mg/kg/day and rabbits up to 5 mg/kg/day. These doses represent exposures 580 and 37 times higher, respectively, than the recommended human ophthalmic dose (RHOD) of brimonidine tartrate/timolol maleate ophthalmic solution at 1 drop in both eyes twice daily.

Orally administered brimonidine crossed the placenta in pregnant rats and entered the fetal circulation to a limited extent. Embryofetal development studies conducted with timolol during organogenesis in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ophthalmic dose of 0.012 mg/kg/day on a mg/kg basis (MRHOD)] 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 (83,000 times the MRHOD) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses 8,300 times the MRHOD without apparent maternotoxicity.

8.2Lactation Risk Summary Timolol has been detected in human milk following oral and ophthalmic drug administration. It is not known whether brimonidine tartrate is excreted in human milk. In animal studies, brimonidine tartrate has been shown to be excreted in breast milk.

Because of the potential for serious adverse reactions in the breastfed infant, including central nervous system depression and apnea, brimonidine tartrate/timolol maleate ophthalmic solution is not recommended for use during lactation. Data Animal Data After a single oral dose of 14 C-labeled brimonidine tartrate to lactating rats, brimonidine tartrate and trace metabolites were detected in milk after 30 minutes. There was 30% higher milk concentration compared to maternal plasma concentration 30 minutes after dosing an…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate/timolol maleate ophthalmic solution in pregnant women. Limited available data from postmarketing safety reports and published literature reviews with brimonidine tartrate/timolol maleate ophthalmic solution use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data) . In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent.

Oral administration of brimonidine tartrate or timolol maleate to pregnant rats and rabbits during organogenesis at dose exposures 580 and 37 times the recommended human ophthalmic dose (RHOD) resulted in no adverse developmental effects (see Data) . Oral administration of timolol maleate to mice, rats, and rabbits during organogenesis at dose exposures up to 4,200 times the RHOD resulted in no evidence of fetal malformations (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by the breastfed infant.

Animal Data Embryo fetal development studies were conducted with oral administration of brimonidine tartrate during organogenesis in rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18). No adverse developmental effects were observed in rats up to 2.5 mg/kg/day and rabbits up to 5 mg/kg/day. These doses represent exposures 580 and 37 times higher, respectively, than the recommended human ophthalmic dose (RHOD) of brimonidine tartrate/timolol maleate ophthalmic solution at 1 drop in both eyes twice daily.

Orally administered brimonidine crossed the placenta in pregnant rats and entered the fetal circulation to a limited extent. Embryofetal development studies conducted with timolol during organogenesis in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ophthalmic dose of 0.012 mg/kg/day on a mg/kg basis (MRHOD)] 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 (83,000 times the MRHOD) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses 8,300 times the MRHOD without apparent maternotoxicity.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in pediatric patients younger than 2 years old [see Contraindications ( 4.3 )] . During post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. The safety and effectiveness of brimonidine tartrate/timolol maleate ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP have been established in pediatric patients aged 2 years and older.

Use of brimonidine tartrate/timolol maleate ophthalmic solution for this indication is supported by evidence from adequate and well-controlled studies of brimonidine tartrate/timolol maleate ophthalmic solution in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). In this well-controlled clinical study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers.

The most commonly observed adverse reactions were somnolence (50% to 83% in patients 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.

🧓 Geriatric Use 19 words ▾

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

🆘 Overdosage 108 words ▾

10 OVERDOSAGE There have been reports of inadvertent overdosage with timolol ophthalmic solution 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. With the exception of hypotension, very limited information exists on accidental ingestion of brimonidine in adults. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine ophthalmic solutions as part of medical treatment of congenital glaucoma or by accidental oral ingestion [see Use in Specific Populations ( 8.4 )] .

Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine tartrate/timolol maleate ophthalmic solution is comprised of two components: brimonidine tartrate and timolol. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage. Brimonidine tartrate/timolol maleate ophthalmic solution is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor. Both brimonidine and timolol have a rapid onset of action, with peak ocular hypotensive effect seen at two hours post-dosing for brimonidine and one to two hours for timolol.

Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. Timolol maleate is a beta 1 and beta 2 adrenergic receptor inhibitor that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity.

12.3Pharmacokinetics Absorption Systemic absorption of brimonidine and timolol was assessed in healthy volunteers and patients following topical dosing with brimonidine tartrate/timolol maleate ophthalmic solution. Normal volunteers dosed with one drop of brimonidine tartrate/timolol maleate ophthalmic solution twice daily in both eyes for seven days showed peak plasma brimonidine and timolol concentrations of 30 pg/mL and 400 pg/mL, respectively. Plasma concentrations of brimonidine peaked at 1 to 4 hours after ocular dosing.

Peak plasma concentrations of timolol occurred approximately 1 to 3 hours post-dose. In a crossover study of brimonidine tartrate/timolol maleate ophthalmic solution, brimonidine tartrate 0.2%, and timolol 0.5% administered twice daily for 7 days in healthy volunteers, the mean brimonidine area-under-the-plasma-concentration-time curve (AUC) for brimonidine tartrate/timolol maleate ophthalmic solution was 128 ± 61 pg•hr/mL versus 141 ± 106 pg•hr/mL for the respective monotherapy treatments; mean Cmax values of brimonidine were comparable following brimonidine tartrate/timolol maleate ophthalmic solution treatment versus monotherapy (32.7 ± 15 pg/mL versus 34.7 ± 22.6 pg/mL, respectively).

Mean timolol AUC for brimonidine tartrate/timolol maleate ophthalmic solution was similar to that of the respective monotherapy treatment (2919 ± 1679 pg•hr/mL versus 2909 ± 1231 pg•hr/mL, respectively); mean Cmax of timolol was approximately 20% lower following brimonidine tartrate/timolol maleate ophthalmic solution treatment versus monotherapy. In a parallel study in patients dosed twice daily with brimonidine tartrate/timolol maleate ophthalmic solution, twice daily with timolol 0.5%, or three times daily with brimonidine tartrate 0.2%, one-hour post dose plasma concentrations of timolol and brimonidine were approximately 30 to 40% lower with brimonidine tartrate/timolol maleate ophthalmic solution than their respective monotherapy values.

The lower plasma brimonidine concentrations with brimonidine tartrate/timolol maleate ophthalmic solution appears to be due to twice-daily dosing for brimonidine tartrate/timolol maleate ophthalmic solution versus three-times dosing with brimonidine tartrate 0.2%. Distribution The protein binding of timolol is approximately 60%. The protein binding of brimonidine is approximately 29%.

Elimination Metabolism In humans, brimonidine is extensively metabolized-by the liver. Timolol is partially metabolized by the liver. Excretion In the crossover study in healthy volunteers, the plasma concentration of brimonidine declined with a systemic half-life of approximately 3 hours.

The apparent systemic half-life of timolol was ab…

🧬 Mechanism of Action 172 words ▾

12.1Mechanism of Action Brimonidine tartrate/timolol maleate ophthalmic solution is comprised of two components: brimonidine tartrate and timolol. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage. Brimonidine tartrate/timolol maleate ophthalmic solution is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor. Both brimonidine and timolol have a rapid onset of action, with peak ocular hypotensive effect seen at two hours post-dosing for brimonidine and one to two hours for timolol.

Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. Timolol maleate is a beta 1 and beta 2 adrenergic receptor inhibitor that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity.

📦 How Supplied / Storage and Handling 91 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate/timolol maleate ophthalmic solution, 0.2%/0.5% is supplied sterile, in white opaque LDPE ratchet modified screw neck bottle fitted with white LDPE nozzle and with Dark blue HDPE Caps as follows: 5 mL in 10 mL bottle NDC 68083-624-01 10 mL in 10 mL bottle NDC 68083-625-01 15 mL in 15 mL bottle NDC 68083-664-01 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light.

Replace the cap after use.

📋 Description 204 words ▾

11 DESCRIPTION Brimonidine tartrate/Timolol maleate ophthalmic solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha -2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are: Brimonidine tartrate: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 Timolol maleate: (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW=432.50 as the maleate salt In solution, brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color.

It has an osmolality of 260 to 330 mOsmol/kg and a pH during its shelf life of 6.5 to 7.3. Brimonidine tartrate appears as pale yellow colored powder to wheatish colored powder and is soluble in water, practically insoluble in anhydrous ethanol and in toluene. Timolol maleate appears as a white or almost white, crystalline powder or colorless crystals and is soluble in water, ethanol (96%) and in methanol, sparingly soluble in chloroform and in propylene glycol, insoluble in ether and in cyclohexane.

Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%, disodium hydrogen phosphate heptahydrate, monobasic sodium phosphate monohydrate, hydrochloric acid and/or sodium hydroxide to adjust pH (6.5 to 7.3), water for injection. Brimonidine-Structure Timolol-Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise 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 to not take this product [see Contraindications ( 4.1 , 4.2 )] . Handling the Container Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections.

Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions or by inadvertent contact with the dropper tip [see Warnings and Precautions ( 5.10 )] . Always replace the cap after using. If solution changes color or becomes cloudy, do not use.

Do not use the product after the expiration date marked on the bottle. When to Seek Physician Advise Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advise concerning the continued use of the present multidose container. Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Contact Lens Use Patients should be advised that brimonidine tartrate/timolol maleate ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of brimonidine tartrate/timolol maleate ophthalmic solution.

Potential for Decreased Mental Alertness As with other similar medications, brimonidine tartrate/timolol maleate ophthalmic solution may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad-500043, India Revised Date: June 2026

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Brimonidine Tartrate and Timolol maleate Ophthalmic Solution (this brand).

Top reported reactions

Blindness4
Eye Disorder4
Blindness Unilateral3
Ocular Hyperaemia3
Death2
Dry Eye2
Eye Pain2

Age at onset

Adult1

Reporter sex

0 reports

Serious outcomes

Disabling2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 7 0
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gland Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gland Pharma Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68083-0619-10 · Gland 68083-0625-01 · Gland →
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.