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Ketorolac Tromethamine 5 mg/mL Solution/ Drops — NDC 65145-0139-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ketorolac Tromethamine 5 mg/mL Solution/ Drops — NDC 65145-139-01 (Billing 65145-0139-01)

by Caplin Steriles Limited · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Ketorolac Tromethamine 5 mg/mL Solution/ Drops from Caplin Steriles Limited, marketed since Jan 2025 and currently FDA-listed; retail pharmacies pay about $1.45 per mL (NADAC). It is this product's only package size.

NDC 65145-0139-01
🏷️ FDA NDC (as labeled) 65145-139-01 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 Jul 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 Ketorolac Tromethamine (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 · Oct 1, 2025 — Presence of Particulate Matter: Particulate matter identified as glass (Aspiro Pharma Limited) · FDA recall D-0036-2026
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-0677-2025
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0494-2025
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) 65145-139-01
Product NDC 65145-139
11-digit billing NDC 65145013901
NCPDP billing unit ML — per mL (volume)
RxCUI 860107
UNII 4EVE5946BQ
UPC 0365145140012, 0365145138019, 0365145139016
Application # ANDA218204
SPL Set ID 4ba4a228-75d6-4a77-bf34-0381b2a89602
Established class (EPC) Anti-Inflammatory Agents; Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-23
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance KETOROLAC TROMETHAMINE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86805035102020
GCN Seq No 019067
GCN 52700
HICL code 005175
Ingredient (HICL) Ketorolac Tromethamine
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 Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name KETOROLAC 0.5% OPHTH SOLUTION
FDB brand name Ketorolac Tromethamine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 019067
  • GCN: 52700
  • GPI-14 (Medi-Span): 86805035102020
  • HICL (First Databank): 005175
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 860107
Why two NDCs? The FDA registers this code as 65145-139-01 — 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 → 65145-0139-01. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitor
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Acetic acid derivatives and related substances, Antiinflammatory agents, non-steroids
How it works Cyclooxygenase Inhibitors
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

Label name KETOROLAC 0.5% OPHTH SOLUTION Ingredient Ketorolac Tromethamine
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The injection, tablets and Sprix nasal spray are for short-term relief of moderate to moderately severe pain in adults. The eye drops treat eye itching from...
  • For pain, no more than 5 days total, counting injection, tablets and spray together. Taking it longer or at higher doses raises the risk of serious side effects without better reli...
  • No. Ketorolac should not be combined with aspirin or other NSAIDs because the risk of stomach bleeding and other serious effects goes up with no extra benefit. Always check with me...
  • Can I take it with ibuprofen or aspirin?
📖 Read our full Ketorolac guide →
1
Nutrient depletion considerations

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

🧪 Full Ketorolac Tromethamine nutrient depletion report →
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.

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 $1.451 $7.25 / 5 ml
Medicaid paysCMS SDUD · 12 mo $2.74 $13.71 / 5 ml
Medicare drug plans payPart D · Q2 2026 $2.30 $11.49 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.541 $1.399
▼ Down 6% over the last 10 months.
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
65145-0139-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 2025-01-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketorolac Tromethamine 5 mg/mL 65145-0140-01 Caplin 1 bottle $1.338 AT Availability likely save 8%
Ketorolac Tromethamine 5 mg/mL 42571-0137-25 Micro 5 ml $1.451 AT Availability likely —
Ketorolac Tromethamine 5 mg/mL 60505-1003-01 Apotex 1 bottle $1.451 AT Availability likely —
Ketorolac Tromethamine 5 mg/mL 61314-0126-05 Sandoz 5 ml $1.451 AT Availability likely —
Ketorolac Tromethamine 5 mg/mLthis 65145-0139-01 Caplin 1 bottle $1.451 AT Availability likely —
Ketorolac Tromethamine 5 mg/mL 47335-0220-90 Sun 1 bottle $1.475 — FDA listed +2%
Acular 5 mg/mL 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 —
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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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.

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 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.
  • 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 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.
  • 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 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 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

LabelerCaplin Steriles Limited
Application holderCAPLIN STERILES LTD
FDA applicationANDA218204 (ANDA)
Labeler code65145
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio88 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 77 words ▾

1 INDICATIONS AND USAGE Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti- inflammatory indicated for: The treatment of inflammation following cataract surgery.

( 1 ) The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 )

⏱️ Dosage and Administration 205 words ▾

2 DOSAGE AND ADMINISTRATION One drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye(s) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine ophthalmic solution should be applied 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 Dosing Patient Dosing The recommended dose of ketorolac tromethamine ophthalmic solution is one drop four times a day to the affected eye(s) for relief of ocular itching due to seasonal allergic conjunctivitis. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

2.2Use with Other Topical Ophthalmic Medications Ketorolac tromethamine ophthalmic solution 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 93 words ▾

3 DOSAGE FORMS AND STRENGTHS 5 mL size bottle filled with 3 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL) 10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL) 10 mL size bottle filled with 10 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL) Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. ( 3 ) 5 mL size bottle filled with 3 mL of solution 10 mL size bottle filled with 5 mL of solution 10 mL size bottle filled with 10 mL of solution

⛔ Contraindications 32 words ▾

4 CONTRAINDICATIONS Ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. Hypersensitivity to any component of this product. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

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 ketorolac tromethamine ophthalmic solution 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.

5.5Contact Lens Wear Ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS 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 Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies 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, corneal edema, iritis, ocular inflammation, ocular irritation, 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 post-marketing use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solution 0.5% or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [see Warnings and Precautions (5.2, 5.4)].

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects. Pregnancy Category C Pregnancy Category C: Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis.

Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Ketorolac tromethamine ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ketorolac tromethamine ophthalmic solution during late pregnancy should be avoided.

8.3Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman.

8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 2 have not been established.

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

🤰 Pregnancy 173 words ▾

8.1Pregnancy Teratogenic Effects. Pregnancy Category C Pregnancy Category C: Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis.

Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Ketorolac tromethamine ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ketorolac tromethamine ophthalmic solution during late pregnancy should be avoided.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 2 have not been established.

🧓 Geriatric Use 20 words ▾

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

🧬 Clinical Pharmacology 185 words ▾

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 39 words ▾

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 72 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ketorolac Tromethamine Ophthalmic solution 0.5% is supplied sterile, in white opaque plastic LDPE bottles with white droppers, with gray high density polyethylene (HDPE) caps as follows: 3mL in 5 mL bottle NDC 65145-138-01 5 mL in 10 mL bottle NDC 65145-139-01 10 mL in 10 mL bottle NDC 65145-140-01 Storage : Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

📋 Description 160 words ▾

11 DESCRIPTION Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is 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 ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg.

Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH. ketorolac-tromethamine-structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Slow or Delayed Healing Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

17.2Avoiding Contamination of the Product Patients should be instructed 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. Also, to avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye following bilateral ocular surgery.

The use of the same bottle of topical eye drops for both eyes following bilateral ocular surgery is not recommended.

17.3Contact Lens Wear Patients should be advised that ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.

17.4Intercurrent Ocular Conditions Patients should be advised 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 ketorolac tromethamine ophthalmic solution.

17.5Concomitant Topical Ocular Therapy Patients should be advised that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Made in India Distributed by : Caplin Steriles USA Inc, Hamilton, NJ 08619. Code: TN/Drugs/TN00003457 August 2024 22200948 ketorolac-tromethamine-caplin-logo

🍼 Nursing Mothers 26 words ▾

8.3Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman.

🧬 Pharmacokinetics 143 words ▾

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).

🔬 Clinical Studies 88 words ▾

14 CLINICAL STUDIES Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis. Two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle. Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

🧪 Nonclinical Toxicology 168 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 125 times and 50 times higher respectively than the maximum recommended human topical ophthalmic daily dose given as QID for itching to affected eyes on a mg/kg basis. Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays.

Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells. Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively.

These doses are respectively 225 and 400 times higher than the typical human topical ophthalmic daily dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 165 words ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 125 times and 50 times higher respectively than the maximum recommended human topical ophthalmic daily dose given as QID for itching to affected eyes on a mg/kg basis. Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays.

Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells. Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively.

These doses are respectively 225 and 400 times higher than the typical human topical ophthalmic daily dose.

📄 Package Label / Principal Display Panel 136 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label - 3mL NDC 65145-138-01 Rx only Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR TOPICAL OPHTHALMIC USE ONLY Sterile 3 mL Carton Label - 3mL NDC 65145-138-01 Rx only Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR TOPICAL OPHTHALMIC USE ONLY Sterile 3 mL Container Label - 5mL NDC 65145-139-01 Rx only Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR TOPICAL OPHTHALMIC USE ONLY Sterile 5 mL Carton Label - 5mL NDC 65145-139-01 Rx only Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR TOPICAL OPHTHALMIC USE ONLY Sterile 5 mL Container Label - 10mL NDC 65145-140-01 Rx only Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR TOPICAL OPHTHALMIC USE ONLY Sterile 10 mL Carton Label - 10mL NDC 65145-140-01 Rx only Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR TOPICAL OPHTHALMIC USE ONLY Sterile 10 mL ketorolac-tromethamine-3ml-container ketorolac-tromethamine-3ml-carton ketorolac-tromethamine-5ml-container ketorolac-tromethamine-5ml-carton ketorolac-tromethamine-10ml-container ketorolac-tromethamine-10ml-carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
40
Units reimbursed last 4 qtrs
210
Gross reimbursed last 4 qtrs
$575.75
Avg / prescription
$14.39
Avg / unit
$2.7417
Latest quarter Q1 2026
28Rx
Medicaid pays / mL
$2.7417
gross reimbursed
vs
NADAC / mL
$1.4509
acquisition cost
=
Spread
+$1.2908
+89% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
65% FFS 35% MCO
Fee-for-service · 26 Rx Managed care · 14 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 70 units · 0.7 per 100k residents MI New York: 140 units · 0.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.70.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 0.7 /100k
2 Michigan 0.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ketorolac Tromethamine — the program that covers self-administered drugs. 27 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ketorolac Tromethamine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.53M
Claims incl. refills
446K
Beneficiaries
349.6K
Spend / beneficiary
$24.38
Spend / claim
$19.12
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 65145-0138-01 · Caplin 65145-0140-01 · Caplin →
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.