Acular Ketorolac Tromethamine 5 mg/mL Solution/ Drops
Other active recalls for Ketorolac Tromethamine (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic ketorolac is used to treat itchy eyes caused by allergies. It also is used to treat swelling and redness (inflammation) that can occur after cataract surgery. Ketorolac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of substances that cause allergy symptoms and inflammation.
Read the full MedlinePlus article ↗- That's actually how ketorolac has to be used — the rules say treatment must always start with an injection, either into a vein or a muscle. The oral tablets are only for continuing...
- Why did my doctor give me a shot first instead of just pills?
- Ketorolac is actually quite hard on your stomach, kidneys, and cardiovascular system when used beyond 5 days — the risks of serious bleeding, ulcers, and other complications go up...
- Why can I only take this for 5 days? My pain might last longer than that.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ketorolac Tromethamine — tap one for details:
Ketorolac Tromethamine 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?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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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.
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UNII 9T1C662FKS
A synthetic detergent and emulsifier derived from octylphenol. It helps blend water and oil-based ingredients together and improves how the medicine disperses in the body, commonly used in injectable and topical formulations.
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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.
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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 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?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $51.19 | $255.97 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $54.45 | $272.25 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketorolac Tromethamine 5 mg/mL 65145-0140-01 | Caplin | 1 bottle | $1.358 | AT | Availability likely | — |
| Ketorolac Tromethamine 5 mg/mL 42571-0137-25 | Micro | 5 ml | $1.448 | AT | Availability likely | — |
| Ketorolac Tromethamine 5 mg/mL 60505-1003-01 | Apotex | 1 bottle | $1.448 | AT | Availability likely | — |
| Ketorolac Tromethamine 5 mg/mL 61314-0126-05 | Sandoz | 5 ml | $1.448 | AT | Availability likely | — |
| Ketorolac Tromethamine 5 mg/mL 65145-0139-01 | Caplin | 1 bottle | $1.448 | AT | Availability likely | — |
| Ketorolac Tromethamine 5 mg/mL 47335-0220-90 | Sun | 1 bottle | $1.475 | — | FDA listed | — |
| Acular 5 mg/mLthis 00023-2181-05 | Allergan, | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 47335-0219-90 | Sun | 1 bottle | — | — | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 47335-0221-90 | Sun | 1 bottle | — | — | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 50090-2746-00 | A-S | 5 ml | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 63187-0628-05 | Proficient | 1 bottle | — | — | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 63187-0777-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 65145-0138-01 | Caplin | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 65862-0770-05 | Aurobindo | 1 bottle | — | — | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 67296-2210-01 | Redpharm | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 67296-2253-01 | Redpharm | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 68071-2252-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 68071-2400-05 | NuCare | 1 bottle | — | — | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 68071-3684-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 68071-3880-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 68788-8549-05 | Preferred | 5 ml | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 69315-0322-03 | Leading | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 70512-0790-03 | SOLA | 1 bottle | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 71205-0296-05 | Proficient | 5 ml | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 72162-2384-02 | Bryant | 5 ml | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 72189-0335-05 | Direct | 5 ml | — | AT | FDA listed | — |
| Ketorolac Tromethamine 5 mg/mL 67296-2318-05 | Redpharm | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00023-2181-05 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER | 1992-12-01 | Active |
🧭 About this NDC listing & data coverage
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) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ACULAR is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. ACULAR is a nonsteroidal anti-inflammatory drug (NSAID) indicated for: The temporary relief of ocular itching due to seasonal allergic conjunctivitis.
( 1 ) The treatment of inflammation following cataract surgery. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ACULAR to the affected eye(s) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, apply one drop of ACULAR to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. ( 2.1 )
2.1Recommended Dosage Temporary Relief o f Ocular Itching D ue t o Seasonal Allergic Conjunctivitis The recommended dosage of ACULAR is one drop four times a day to the affected eye(s) for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Treatment o f Postoperative Inflammation i n Patients Who Have Undergone Cataract Extraction Apply one drop of ACULAR to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
2.2Use with Other Topical Ophthalmic Medications ACULAR has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL). Ophthalmic solution containing 0.5% (5 mg/mL) ketorolac tromethamine. ( 3 ) 10 mL size bottle filled with 5 mL of solution
⛔ Contraindications ▾
4 CONTRAINDICATIONS ACULAR solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions ( 6.1 )] . Hypersensitivity to any component of this product. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Delayed healing ( 5.1 ) Cross-sensitivity or hypersensitivity ( 5.2 ) Increased bleeding time due to interference with thrombocyte aggregation ( 5.3 ) Corneal effects including keratitis ( 5.4 )
5.1Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
5.2Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine ophthalmic solution in patients who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
5.3Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ACULAR be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.
5.4Corneal Effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.
Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
5.5Risk of Contamination Avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to 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.
5.6Contact Lens Wear ACULAR should not be administered while wearing contact lenses.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Delayed Healing [see Warnings and Precautions ( 5.1 )] Cross-Sensitivity or Hypersensitivity [see Warnings and Precautions ( 5.2 )] Increased Bleeding Time [see Warnings and Precautions ( 5.3 )] Corneal Effects [see Warnings and Precautions ( 5.4 )] The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials.
Other adverse reactions occurring approximately 1% to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritus), corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections. Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug. Eye Disorders: corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown.
Respiratory, Thoracic and Mediastinal Disorders: bronchospasm or exacerbation of asthma.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ACULAR in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ACULAR at clinically relevant doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACULAR during late pregnancy should be avoided.
8.2Lactation Risk Summary It is not known whether ketorolac when given topically is present in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACULAR is administered to a nursing woman.
8.4Pediatric Use The safety and effectiveness of ACULAR have not been established in pediatric patients younger than 2 years old.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ACULAR in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ACULAR at clinically relevant doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACULAR during late pregnancy should be avoided.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ACULAR have not been established in pediatric patients younger than 2 years old.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.
12.3Pharmacokinetics Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL). One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into 1 eye and 1 drop of vehicle into the other eye TID in 26 healthy subjects. Five (5) of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at Day 10 during topical ocular treatment.
The range of concentrations following TID dosing of 0.5% ketorolac tromethamine ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (290 ± 70 ng/mL).
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING ACULAR (ketorolac tromethamine ophthalmic solution) 0.5% is supplied sterile, in white opaque plastic (LDPE) bottles with white droppers, with gray high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 0023-2181-05 Storage: Store at 15°C to 25°C (59°F to 77°F). Protect from light.
📋 Description ▾
11 DESCRIPTION ACULAR (ketorolac tromethamine ophthalmic solution) 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: ACULAR ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine.
Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5.
This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ACULAR ophthalmic solution is 290 mOsmol/kg.
Each mL of ACULAR ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative : benzalkonium chloride 0.01%. Inactives : edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Slow or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs). Avoiding Contamination of the Product Instruct patients to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to 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.
Contact Lens Wear Advise patients that ACULAR should not be administered while wearing contact lenses. Intercurrent Ocular Conditions Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of ACULAR. Concomitant Topical Ocular Therapy Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.
Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2025 AbbVie. All rights reserved.
ACULAR and its design are trademarks of Allergan, Inc., an AbbVie company. 20091161 Shape Description automatically generated