HomeNDC LookupIngredientsCarteolol Hydrochloride › 61314-0238-15
Carteolol Hydrochloride 10 mg/mL Solution, 15 mL — NDC 61314-0238-15 package photo

Carteolol Hydrochloride 10 mg/mL Solution, 15 mL

by Sandoz Inc · 15 mL in 1 BOTTLE, PLASTIC (61314-238-15)
NDC 61314-0238-15
🏷️ FDA NDC (as labeled) 61314-238-15 billing pads the product segment with a zero
This package
Contains15 mL Cost per mL$1.29 NADAC Per package$19.37 / 15 ml Pack sizes3 compare ↓
Also priced by: Part D plans $2.53/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 61314-238-15
Product NDC 61314-238
11-digit billing NDC 61314023815
NCPDP billing unit ML — per mL (volume)
RxCUI 978573
UNII 4797W6I0T4
Application # ANDA075476
SPL Set ID 571fe550-399d-4296-835c-37aa1ab9b409
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-01-05
Route OPHTHALMIC
Dosage form SOLUTION
Substance CARTEOLOL HYDROCHLORIDE
GPI-14 86250012102005
GPI class Carteolol HCl
GCN Seq No 016489
GCN 32261
HICL code 002110
Ingredient (HICL) Carteolol Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.08.00
AHFS class Beta-Adrenergic Blocking Agents (52:40)
FDB label name CARTEOLOL HCL 1% EYE DROPS
FDB brand name Carteolol Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 61314-238-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61314-0238-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 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.

🏭 Manufacturer & labeler

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA075476 (ANDA)
Labeler code61314
First marketedJan 2000
Product typeHuman Prescription Drug
Portfolio387 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.

🩺 Clinical

Label name CARTEOLOL HCL 1% EYE DROPS Ingredient Carteolol Hcl
1
Nutrient depletion considerations

Carteolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 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.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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.

💲 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 $1.291 $19.37 / 15 ml
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 · Q2 2026 $2.53 $37.94 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Mar 2025 $1.291 $1.291
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carteolol Hydrochloride 10 mg/mLthis 61314-0238-15 Sandoz 15 ml $1.291 Availability likely
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

🏛️
2000
On the market since
Jan 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
5 ml61314-0238-05 455 Rx · $10,075
1 ml61314-0238-10 No Medicaid data
15 ml this page61314-0238-15 No Medicaid data
Drug total (last 4 qtrs): 455 Rx · 2,735 units · $10,075 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Carteolol Hydrochloride — the ingredient across all brands.

Top reported reactions

Intraocular Pressure Increased18
Cataract14
Malaise13
Bradycardia11
Eye Pain11
Visual Acuity Reduced11
Diarrhoea9

Age at onset

Infant1
Adolescent1
Adult5
Elderly28

Reporter sex

331 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization150
Life-threatening28
Disabling10
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 40 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
61314-0238-05 5 mL in 1 BOTTLE, PLASTIC (61314-238-05) $1.56 / mL $7.82 2000-01-05 Active
61314-0238-10 10 mL in 1 BOTTLE, PLASTIC (61314-238-10) $1.41 / mL $14.09 2000-01-05 Active
61314-0238-15 You're viewing this 15 mL in 1 BOTTLE, PLASTIC (61314-238-15) $1.29 / mL $19.37 2000-01-05 Active

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

This pack has the lowest per-mL cost of the 3 priced pack sizes ($1.29 NADAC).

This pack shows little to no recent Medicaid volume — the 5 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 61314-0238-15?
NDC 61314-0238-15 contains 15 mL — 15 ml in 1 bottle, plastic.
What is the difference between NDC 61314-0238-15 and NDC 61314-0238-05?
Both are Carteolol Hydrochloride 10 mg/mL Solution — the drug itself is identical. NDC 61314-0238-15 is the 15 mL package, while NDC 61314-0238-05 is the 5 ml package. Per-mL NADAC also differs: $1.29 here vs $1.56 for the 5 ml pack.
What NDC number is used to bill for this package of Carteolol Hydrochloride 10 mg/mL Solution?
Bill NDC 61314-0238-15 — the 11-digit billing format is 61314023815. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 45 words

INDICATIONS AND USAGE Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.

⏱️ Dosage and Administration 58 words

DOSAGE AND ADMINISTRATION The usual dose is one drop of Carteolol Hydrochloride Ophthalmic Solution 1% in the affected eye(s) twice a day. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine or dipivefrin, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.

Contraindications 49 words

CONTRAINDICATIONS Carteolol is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS ); sinus bradycardia; second- and third-degree atrioventricular block; overt cardiac failure (see WARNINGS ); cardiogenic shock; or hypersensivity to any component of this product.

⚠️ Warnings ~2 min read

WARNINGS Carteolol has not been detected in plasma following ocular instillation. However, as with other topically applied ophthalmic preparations, Carteolol may be 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 with topical application of beta-adrenergic blocking agents (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, Carteolol Hydrochloride should be discontinued. Non-Allergic Bronchospasm: In patients with non-allergic bronchospasm or with a history of non-allergic bronchospasm (e.g., chronic bronchitis, emphysema), Carteolol Hydrochloride Ophthalmic Solution should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta 2 receptors.

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 been subject to protracted severe hypotension during anesthesia. For these reasons, in patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents may be appropriate. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (see OVERDOSAGE ).

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 which might precipitate a thyroid storm.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS The following adverse reactions have been reported in clinical trials with Carteolol Hydrochloride Ophthalmic Solution. Ocular: Transient eye irritation, burning, tearing, conjunctival hyperemia and edema occurred in about 1 of 4 patients. Ocular symptoms including blurred and cloudy vision, photophobia, decreased night vision, and ptosis and ocular signs including blepharoconjunctivitis, abnormal corneal staining, and corneal sensitivity occurred occasionally.

Systemic: As is characteristic of nonselective adrenergic blocking agents, Carteolol may cause bradycardia and decreased blood pressure (See WARNINGS ). The following systemic events have occasionally been reported with the use of Carteolol Hydrochloride Ophthalmic Solution: cardiac arrhythmia, heart palpitation, dyspnea, asthenia, headache, dizziness, insomnia, sinusitis, and taste perversion. The following additional adverse reactions have been reported with ophthalmic use of beta 1 and beta 2 (nonselective) adrenergic receptor blocking agents: Body As a Whole: Headache Cardiovascular: Arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation (see WARNINGS ).

Digestive: Nausea Psychiatric: Depression Skin: Hypersensitivity, including localized and generalized rash Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure (see WARNINGS ) Endocrine: Masked symptoms of hypoglycemia in insulin-dependent diabetics (see WARNINGS ) Special Senses: Signs and symptoms of keratitis, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis. Other reactions associated with the oral use of nonselective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.

🔄 Drug Interactions 72 words

Drug Interactions Carteolol Hydrochloride Ophthalmic Solution should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade. 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 produce vertigo, syncope, or postural hypotension.

🤰 Pregnancy 1 words

Pregnancy

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 158 words

OVERDOSAGE No specific information on emergency treatment of overdosage in humans is available. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. The most common effects expected with overdosage of a beta-adrenergic blocking agent are bradycardia, bronchospasm, congestive heart failure and hypotension.

In case of ingestion, treatment with Carteolol Hydrochloride Ophthalmic Solution should be discontinued and gastric lavage considered. The patient should be closely observed and vital signs carefully monitored. The prolonged effects of carteolol must be considered when determining the duration of corrective therapy.

On the basis of the pharmacologic profile, the following additional measures should be considered as appropriate: Symptomatic Sinus Bradycardia or Heart Block: Administer atropine. If there is no response to vagal blockade, administer isoproterenol cautiously. Bronchospasm: Administer a beta 2 -stimulating agent such as isoproterenol and/or a theophylline derivative.

Congestive Heart Failure: Administer diuretics and digitalis glycosides as necessary. Hypotension: Administer vasopressors such as intravenous dopamine, epinephrine or norepinephrine bitartrate.

🧬 Clinical Pharmacology 141 words

CLINICAL PHARMACOLOGY Carteolol is a nonselective beta-adrenergic blocking agent with associated intrinsic sympathomimetic activity and without significant membrane-stabilizing activity. Carteolol Hydrochloride reduces normal and elevated intraocular pressure (IOP) whether or not accompanied by glaucoma. The exact mechanism of the ocular hypotensive effect of beta-blockers has not been definitely demonstrated.

In general, beta-adrenergic blockers reduce cardiac output in patients in good and poor cardiovascular health. In patients with severe impairment of myocardial function, beta-blockers may inhibit the sympathetic stimulation necessary to maintain adequate cardiac function. Beta-adrenergic blockers may also increase airway resistance in the bronchi and bronchioles due to unopposed parasympathetic activity.

Given topically twice daily in controlled domestic clinical trials ranging from 1.5 to 3 months, Carteolol Hydrochloride produced a median percent reduction of IOP 22% to 25%. No significant effects were noted on corneal sensitivity, tear secretion, or pupil size.

📦 How Supplied / Storage and Handling 47 words

HOW SUPPLIED Carteolol Hydrochloride Ophthalmic Solution USP, 1% is supplied as a sterile ophthalmic solution in plastic dispenser bottles of 5 mL (NDC 61314-238-05), 10 mL (NDC 61314-238-10) and 15 mL (NDC 61314-238-15). Store at 15° to 25°C (59° to 77°F) (room temperature) and protect from light.

📋 Description 86 words

DESCRIPTION Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows: C 16 H 24 N 2 O 3 •HCI Mol.

Wt. 328.84 Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%).

Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water. chemical

💬 Information for Patients 46 words

Information to the Patient For topical use only. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. Protect from light.

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