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Ketorolac Tromethamine 5 mg/mL Solution — NDC 63187-0628-05 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 — NDC 63187-628-05 (Billing 63187-0628-05)

by Proficient Rx LP · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Ketorolac Tromethamine 5 mg/mL Solution from Proficient Rx LP, marketed since Nov 2009 and currently FDA-listed. It is this product's only package size.

NDC 63187-0628-05
🏷️ FDA NDC (as labeled) 63187-628-05 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

NDC database record

One package, one record: these facts belong to NDC 63187-628-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63187 labeler · 628 product · 05 package
Package marketed since
Dec 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6318762805 5
FDA record last changed
Jul 24, 2026
⚠️
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) 63187-628-05
Product NDC 63187-628
11-digit billing NDC 63187062805
RxCUI 860107
UNII 4EVE5946BQ
Application # ANDA078434
SPL Set ID fc8ba956-4d3d-4f52-ac8e-89d52a480b48
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 2009-11-05
Route OPHTHALMIC
Dosage form SOLUTION
Substance KETOROLAC TROMETHAMINE
Quick answers
  • RxCUI (RxNorm): 860107
Why two NDCs? The FDA registers this code as 63187-628-05 — 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 → 63187-0628-05. 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

📖 What it is MedlinePlus · NLM

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 ↗
📗 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $2.30 $11.49 / 5 ml
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
63187-0628-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 2018-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 —
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/mL 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 —
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/mLthis 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

🏛️
2009
On the market since
Nov 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.

💡 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

LabelerProficient Rx LP
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA078434 (ANDA)
Labeler code63187
First marketedNov 2009
Product typeHuman Prescription Drug
Portfolio1,729 products on file

More NDCs from Proficient Rx LP labeler code 63187

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

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.

⏱️ Dosage and Administration 102 words ▾

DOSAGE AND ADMINISTRATION The recommended dose of Ketorolac Tromethamine Ophthalmic Solution is one drop (0.25 mg) 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(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

Ketorolac Tromethamine Ophthalmic Solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Ketorolac Tromethamine Ophthalmic Solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

⚠️ Warnings 77 words ▾

WARNINGS There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. With some nonsteroidal anti-inflammatory drugs, 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.

🤒 Adverse Reactions 179 words ▾

ADVERSE REACTIONS The most frequent adverse events reported with the use of ketorolac ophthalmic solution have been transient stinging and burning on instillation. These events were reported by up to 40% of patients participating in clinical trials. Other adverse events occurring approximately 1% - 10% of the time during treatment with ketorolac ophthalmic solution including allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

Other adverse events reported rarely with the use of ketorolac tromethamine ophthalmic solutions included corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision). Clinical Practice: The following events have been identified during postmarketing 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 events, 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, including corneal erosion, corneal perforation, corneal thinning and epithelial breakdown (see PRECAUTIONS, General ).

🤰 Pregnancy 122 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C. Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses up to 109 times and 303 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals. When administered to rats after Day 17 of gestation at oral doses up to 45 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals, 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.

🧒 Pediatric Use 34 words ▾

Pediatric Use: Safety and efficacy in pediatric patients below the age of 3 have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY 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. Ketorolac tromethamine given systemically does not cause pupil constriction.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms.

Two drops (0.1 mL) of 0.5% Ketorolac Tromethamine Ophthalmic Solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved measurable levels in 8 of 9 patients' eyes (mean ketorolac concentration 95 ng/mL aqueous humor, range 40 to 170 ng/mL). Ocular administration of ketorolac tromethamine reduces prostaglandin E 2 (PGE 2 ) levels in aqueous humor. The mean concentration of PGE 2 was 80 pg/mL in the aqueous humor of eyes receiving vehicle and 28 pg/mL in the eyes receiving ketorolac ophthalmic solution, 0.5%.

One drop (0.05 mL) of 0.5% Ketorolac Tromethamine Ophthalmic Solution was instilled into one eye and one drop of vehicle into the other eye TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22.5 ng/mL) at Day 10 during topical ocular treatment. When ketorolac tromethamine 10 mg is administered systemically every 6 hours, peak plasma levels at steady state are around 960 ng/mL.

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.

📦 How Supplied / Storage and Handling 77 words ▾

HOW SUPPLIED Ketorolac Tromethamine Ophthalmic Solution is supplied sterile in white LDPE plastic bottles with natural droppers and gray short skirt caps as follows: 5 mL in l0 mL bottle - NDC 63187-628-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use.

Rx only Manufactured by: Akorn, Inc. Lake Forest, IL 60045 KR00N Rev.05/12 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

📋 Description 186 words ▾

DESCRIPTION Ketorolac Tromethamine Ophthalmic Solution 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)-l,3-propanediol(1:1) and it has the following structural formula: The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is C 15 H 13 NO 3 •C 4 H 11 NO 3 . 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 Ophthalmic Solution is 290 mOsml/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains: Active: ketorolac tromethamine 0.5% Inactives: edetate disodium 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.8 to 7.4) and purified water. Preservative: benzalkonium chloride 0.01% Structural Formula

💬 Information for Patients 15 words ▾

Information for Patients: Ketorolac Tromethamine Ophthalmic Solution should not be administered while wearing contact lenses.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General : All 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.

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 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. 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.

Information for Patients: Ketorolac Tromethamine Ophthalmic Solution should not be administered while wearing contact lenses. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Ketorolac tromethamine was not carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (151 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (60 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals).

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 272 and 484 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals. Pregnancy: Teratogenic Effects: Pregnancy Category C. Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses up to 109 times and 303 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals.

When administered to rats after Day 17 of gestation at oral doses up to 45 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals, 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. Nursing Mothers: Caution should be exercised when Ketorolac Tromethamine Ophthalmic Solution is administered to a… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 17 words ▾

Nursing Mothers: Caution should be exercised when Ketorolac Tromethamine Ophthalmic Solution is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Ketorolac tromethamine was not carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (151 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (60 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals). 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 272 and 484 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses up to 109 times and 303 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals. When administered to rats after Day 17 of gestation at oral doses up to 45 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals, 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.

Nursing Mothers: Caution should be exercised when Ketorolac Tromethamine Ophthalmic Solution is administered to a nursing woman. Pediatric Use: Safety and efficacy in pediatric patients below the age of 3 have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

📄 Package Label / Principal Display Panel 20 words ▾

Principal Display Panel Text for Container Label: NDC 63187-628-05 Ketorolac Tromethamine Ophthalmic Solution 0.5% Sterile Rx only 5 mL 63187-628-05

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

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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63187-0626-30 · Proficient 63187-0631-10 · Proficient →
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.