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Ketorolac Tromethamine 5 mg/mL Solution/ Drops — NDC 60505-1003-02 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 60505-1003-2 (Billing 60505-1003-02)

by Apotex Corp. · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Ketorolac Tromethamine 5 mg/mL Solution/ Drops from Apotex Corp., marketed since Dec 2009 and currently FDA-listed; retail pharmacies pay about $1.34 per mL (NADAC).

NDC 60505-1003-02
🏷️ FDA NDC (as labeled) 60505-1003-2 billing pads the package segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$1.34 NADAC Per package$13.38 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $2.19/unit · Part D plans $2.30/unit — full pricing hub ↓
Product page 60505-1003-01 Also comes in: 5 mL 60505-1003-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 60505-1003-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60505 labeler · 1003 product · 2 package
Package marketed since
Dec 7, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6050510032 3
Medicaid fills, this package
5,359 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
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
Lots / codes: Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316 · reported Oct 8, 2025
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0494-2025
Lots / codes: Batch TZ1236, Exp Date: 11/30/2025 · reported Jul 2, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Ketorolac Tromethamine (different manufacturers) — 1 · 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
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) 60505-1003-2
Product NDC 60505-1003
11-digit billing NDC 60505100302
NCPDP billing unit ML — per mL (volume)
RxCUI 860107
UNII 4EVE5946BQ
Application # ANDA076109
SPL Set ID d9a186ba-74a9-b6d4-1109-1e045ba1763e
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 2009-12-07
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

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
  • HICL (First Databank): 005175
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 860107
Why two NDCs? The FDA registers this code as 60505-1003-2 — a 5-4-1 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 package segment → 60505-1003-02. 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 $1.338 $13.38 / 10 ml
Medicaid paysCMS SDUD · 12 mo $2.19 $21.86 / 10 ml
Medicare drug plans payPart D · Q2 2026 $2.30 $22.99 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.550 $1.155
▼ Down 4% over the last 24 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 Per unit Per pack Marketing startMarketing endStatus
60505-1003-01 60505-1003-1 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $1.45 / mL $7.25 2009-12-07 — Active
60505-1003-02 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER $1.34 / mL $13.38 2009-12-07 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($1.34 NADAC).

This pack accounts for about 16% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Ketorolac Tromethamine 5 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketorolac Tromethamine 5 mg/mLthis 60505-1003-02 Apotex 1 bottle $1.338 AT Availability likely —
Ketorolac Tromethamine 5 mg/mL 65145-0140-01 Caplin 1 bottle $1.338 AT Availability likely —
Ketorolac Tromethamine 5 mg/mL 42571-0137-25 Micro 5 ml $1.451 AT Availability likely +8%
Ketorolac Tromethamine 5 mg/mL 61314-0126-05 Sandoz 5 ml $1.451 AT Availability likely +8%
Ketorolac Tromethamine 5 mg/mL 65145-0139-01 Caplin 1 bottle $1.451 AT Availability likely +8%
Ketorolac Tromethamine 5 mg/mL 47335-0220-90 Sun 1 bottle $1.475 — FDA listed +10%
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 —
Ketorolac Tromethamine 5 mg/mL 85766-0301-03 Sportpharm 3 ml — 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

🏛️
2009
On the market since
Dec 2009
📍
2026
Currently FDA-listed
17 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.

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Ketorolac inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA076109 (ANDA)
Labeler code60505
First marketedDec 2009
Product typeHuman Prescription Drug
Portfolio313 products on file

More NDCs from Apotex Corp. labeler code 60505

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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 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 temporary relief of ocular itching due to seasonal allergic conjunctivitis.

( 1 ) The treatment of inflammation following cataract surgery. ( 1 )

⏱️ Dosage and Administration 211 words ▾

2 DOSAGE AND ADMINISTRATION For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ketorolac tromethamine 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 ketorolac tromethamine 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 of Ocular Itching Due to Seasonal Allergic Conjunctivitis The recommended dosage of ketorolac tromethamine 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 of Postoperative Inflammation in Patients Who Have Undergone Cataract Extraction Apply one drop of ketorolac tromethamine 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 Ketorolac tromethamine 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 75 words ▾

3 DOSAGE FORMS AND STRENGTHS Ketorolac tromethamine ophthalmic solution 0.5% is supplied sterile in white opaque LDPE plastic bottles with white opaque droppers with grey opaque ophthalmic HDPE plastic caps as follows: 11 mL size bottle filled with 5 mL or 10 mL ketorolac tromethamine ophthalmic solution, 0.5%. Ophthalmic solution containing 0.5% (5 mg/mL) ketorolac tromethamine. ( 3 ) 11 mL size bottle filled with 5 mL or 10 mL ketorolac tromethamine ophthalmic solution, 0.5%.

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS Ketorolac tromethamine 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 ~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 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 Ketorolac tromethamine should not be administered while wearing contact lenses.

🤒 Adverse Reactions ~1 min read ▾

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 Apotex Corp. at 1-800-706-5575 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 pruritis), 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 180 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ketorolac tromethamine in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ketorolac tromethamine 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 ketorolac tromethamine 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 ketorolac tromethamine is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of ketorolac tromethamine 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 95 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ketorolac tromethamine in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ketorolac tromethamine 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 ketorolac tromethamine during late pregnancy should be avoided .

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use The safety and effectiveness of ketorolac tromethamine have not been established in pediatric patients younger than 2 years old.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall 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 60 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ketorolac Tromethamine Ophthalmic Solution 0.5% is supplied sterile in white opaque LDPE plastic bottles with white opaque droppers with grey opaque ophthalmic HDPE plastic caps as follows: 5 mL - NDC 60505-1003-1 and 10 mL - NDC 60505-1003-2. Store at 20 °C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.

📦 Storage and Handling 17 words ▾

Store at 20 °C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.

📋 Description 165 words ▾

11 DESCRIPTION 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 Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine 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 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 dihydrate 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and water for injection.

Chemical Structure

💬 Information for Patients 187 words ▾

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 ketorolac tromethamine 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 ketorolac tromethamine. 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.

Rx only APOTEX INC. KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% Manufactured by: Manufactured for: Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, FL 33326 Canada M9L 1T9 Revised: July 2026

🍼 Nursing Mothers 39 words ▾

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 ketorolac tromethamine 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.

📄 Recent Major Changes 10 words ▾

RECENT MAJOR CHANGES Warnings and Precautions ( 5.5 ) 9/2025

📄 Package Label / Principal Display Panel 32 words ▾

Representative sample of labeling (see the HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 0.5% BOTTLE LABEL APOTEX CORP. NDC 60505-1003-1 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% Rx only 5 ml

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.
📅 Q1 2025 – Q1 2026 · 5 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
5.4K
Units reimbursed last 4 qtrs
53K
Gross reimbursed last 4 qtrs
$115.8K
Avg / prescription
$21.61
Avg / unit
$2.1855
Latest quarter Q1 2026
670Rx
Medicaid pays / mL
$2.1855
gross reimbursed
vs
NADAC / mL
$1.3384
acquisition cost
=
Spread
+$0.8471
+63% 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 ⓘ
53% FFS 47% MCO
Fee-for-service · 2,842 Rx Managed care · 2,517 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 930 units · 11.9 per 100k residents WA Idaho: 310 units · 15.8 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 940 units · 16.4 per 100k residents MN Wisconsin: 1,950 units · 33.0 per 100k residents WI Michigan: 2,405 units · 24.0 per 100k residents MI New York: 9,110 units · 46.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 705 units · 16.7 per 100k residents OR Nevada: 300 units · 9.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 460 units · 14.3 per 100k residents IA Illinois: 4,155 units · 33.1 per 100k residents IL Indiana: 520 units · 7.6 per 100k residents IN Ohio: 1,960 units · 16.6 per 100k residents OH Pennsylvania: 995 units · 7.7 per 100k residents PA New Jersey: 350 units · 3.8 per 100k residents NJ Massachusetts: 1,185 units · 16.9 per 100k residents MA California: 12,601 units · 32.3 per 100k residents CA Utah: no data reported UT Colorado: 1,060 units · 18.0 per 100k residents CO Nebraska: no data reported NE Missouri: 600 units · 9.7 per 100k residents MO Kentucky: 954 units · 21.1 per 100k residents KY West Virginia: 130 units · 7.3 per 100k residents WV Virginia: 910 units · 10.4 per 100k residents VA Maryland: 1,976 units · 32.0 per 100k residents MD Connecticut: 140 units · 3.9 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,120 units · 15.1 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 705 units · 9.9 per 100k residents TN North Carolina: 685 units · 6.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 250 units · 6.2 per 100k residents OK Louisiana: 1,195 units · 26.1 per 100k residents LA Mississippi: no data reported MS Alabama: 110 units · 2.2 per 100k residents AL Georgia: 235 units · 2.1 per 100k residents GA D.C.: 185 units · 27.2 per 100k residents DC Hawaii: no data reported HI Texas: 2,685 units · 8.8 per 100k residents TX Florida: 1,185 units · 5.2 per 100k residents FL
Units reimbursed · per 100k residents
2.146.5
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 46.5 /100k
2 Illinois 33.1 /100k
3 Wisconsin 33.0 /100k
4 California 32.3 /100k
5 Maryland 32.0 /100k
6 D.C. 27.2 /100k
7 Louisiana 26.1 /100k
8 Michigan 24.0 /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.

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.
1 bottle60505-1003-01 27,183 Rx · $437,889
1 bottle this page60505-1003-02 5,359 Rx · $115,833
Drug total (last 4 qtrs): 32,542 Rx · 199,201 units · $553,721 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
← 60505-0955-01 · Apotex 60505-1006-01 · Apotex →
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.