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KETOROLAC TROMETHAMINE 30 mg/mL Injection, Solution, 1 mL — NDC 51662-1292-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

KETOROLAC TROMETHAMINE 30 mg/mL Injection, Solution, 1 mL — NDC 51662-1292-1 (Billing 51662-1292-01)

by HF Acquisition Co LLC, DBA HealthFirst · 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 mL of KETOROLAC TROMETHAMINE 30 mg/mL Injection, Solution from HF Acquisition Co LLC, DBA HealthFirst, marketed since Sep 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 51662-1292-01
🏷️ FDA NDC (as labeled) 51662-1292-1 billing pads the package segment with a zero
This package
Contains1 mL Pack sizes2 compare ↓
Main listing for product 51662-1292 · Also comes in: 25 pouches 51662-1292-3
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) 51662-1292-1
Product NDC 51662-1292
11-digit billing NDC 51662129201
RxCUI 1665459, 1665461
UNII 4EVE5946BQ
Application # ANDA074802
SPL Set ID 76446045-3cca-0206-e053-2a91aa0a2440
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 2018-09-19
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance KETOROLAC TROMETHAMINE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1665459
Why two NDCs? The FDA registers this code as 51662-1292-1 — 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 → 51662-1292-01. 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

📖 What it is MedlinePlus · NLM

Ketorolac is used to relieve moderately severe pain in adults, usually after surgery. Ketorolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, 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 · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1885 $0.286 / J1885 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)51662-1292-1
11-digit billing NDC51662-1292-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1885
DescriptorInjection, ketorolac tromethamine, per 15 mg
Billing units / pkg2 units
Medicare Part B spend (2026 (Q1))$302,901 · 440,857 claims · $0.69 per claim (all NDCs under J1885)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1292-01 You're viewing this Main listing 1 mL in 1 VIAL, SINGLE-DOSE 2018-09-19 — Active
51662-1292-03 51662-1292-3 25 POUCH in 1 CASE / 1 mL in 1 POUCH 2020-09-04 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 mL — 1 ml in 1 vial, single-dose.
How does this package differ from NDC 51662-1292-03?
Both are KETOROLAC TROMETHAMINE 30 mg/mL Injection, Solution — the drug itself is identical. This page's package is the 1 mL one, while NDC 51662-1292-03 is the 25 pouches package.
What NDC number is used to bill for this package of KETOROLAC TROMETHAMINE 30 mg/mL Injection, Solution?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ketorolac tromethamine 30 mg/mL 72266-0119-25 FOSUN 25 vials $0.552 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 72603-0161-25 NorthStar 25 vials $0.879 AP Discontinued —
Ketorolac Tromethamine 30 mg/mL 00338-0072-25 Baxter 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 00409-3795-01 Hospira, 25 vials $1.017 AP Discontinued —
Ketorolac Tromethamine 30 mg/mL 00641-6042-25 Hikma 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 25021-0701-01 Sagent 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 31722-0306-25 Camber 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 62332-0600-25 Alembic 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 63323-0162-01 Fresenius 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 65145-0145-25 Caplin 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 68462-0756-25 GLENMARK 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 70512-0843-25 SOLA 25 vials $1.017 AP Availability likely —
ketorolac tromethamine 30 mg/mL 72266-0118-25 FOSUN 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 72572-0355-25 Civica, 25 vials $1.017 AP Availability likely —
Ketorolac Tromethamine 30 mg/mL 72572-0357-25 Civica, 25 vials $1.017 AP Availability likely —
Ketorolac tromethamine 30 mg/mL 00404-9996-01 Henry 1 vial — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 43066-0051-10 Baxter 10 vials — AP FDA listed —
ketorolac tromethamine 30 mg/mL 47335-0934-45 Sun 25 vials — — FDA listed —
Ketorolac tromethamine 30 mg/mL 50090-5428-00 A-S 25 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mLthis 51662-1292-01 HF 1 ml — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 51662-1594-03 HF 25 pouches — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 55150-0340-01 Eugia 1 vial — — FDA listed —
Ketorolac Tromethamine 30 mg/mL 55154-0120-05 Cardinal 5 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 55154-7833-05 Cardinal 5 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 55154-9368-05 Cardinal 5 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 55154-9398-05 Cardinal 5 vials — AP FDA listed —
ketorolac tromethamine 30 mg/mL 68083-0133-10 Gland 10 vials — AP FDA listed —
ketorolac tromethamine 30 mg/mL 70518-2927-00 REMEDYREPACK 25 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 71205-0582-01 Proficient 1 vial — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 71872-7185-01 Medical 1 vial — AP FDA listed —
Ketorolac tromethamine 30 mg/mL 71872-7213-01 Medical 1 vial — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 71872-7327-01 Medical 1 vial — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 71872-7363-01 Medical 1 vial — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 83270-0154-03 Onesource 25 vials — — FDA listed —
Ketorolac Tromethamine 30 mg/mL 84549-0701-01 ProPharma 1 ml — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 85766-0064-25 Sportpharm 25 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 00641-6043-25 Hikma 25 vials — AP FDA listed —
Ketorolac tromethamine 30 mg/mL 00404-9997-02 Henry 1 vial — AP FDA listed —
ketorolac tromethamine 30 mg/mL 68083-0134-10 Gland 10 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 72189-0583-01 Direct_rx 1 ml — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 43066-0053-10 Baxter 10 vials — AP FDA listed —
ketorolac tromethamine 30 mg/mL 85766-0017-25 Sportpharm 25 vials — AP FDA listed —
ketorolac tromethamine 30 mg/mL 70518-3800-00 REMEDYREPACK 25 vials — AP FDA listed —
ketorolac tromethamine 30 mg/mL 84549-0119-25 ProPharma 2 ml — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 00487-6232-01 Nephron 30 vials — AP FDA listed —
Ketorolac Tromethamine 30 mg/mL 51662-1702-03 HF 25 pouches — AP 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderHOSPIRA INC
FDA applicationANDA074802 (ANDA)
Labeler code51662
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio333 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information
🚨 Boxed Warning 4 words ▾

BOXED WARNING BOXED WARNING

🎯 Indications and Usage ~1 min read ▾

INDICATIONS & USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS) . Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS , PRECAUTIONS , DOSAGE & ADMINISTRATION , and ADVERSE REACTIONS ).

Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated.

Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see DOSAGE & ADMINISTRATION – Pharmaceutical Information for Ketorolac Tromethamine Injection).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.

In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine. Note: Oral formulation should not be given as an initial dose.

Use minimum effective dose for the individual patient. Total duration of treatment in adult patients: the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. KETOROLAC TROMETHAMINE INJECTION Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or "prn" schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. When administering ketorolac tromethamine injection, the intravenous bolus must be given over no less than 15 seconds.

The intramuscular administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing intravenous or intramuscular. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment: The following regimen should be limited to single administration use only Intramuscular Dosing • Patients <65 years of age: One dose of 60 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg. Intravenous Dosing • Patients <65 years of age: One dose of 30 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg. Multiple-Dose Treatment (Intravenous or Intramuscular) • Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours.

The maximum daily dose for these populations should not exceed 120 mg. • For patients ≥65 years of age, renally impaired patients (see WARNINGS ), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine.

Consideration should be given to supplementing these regimens with low doses of opioids "prn" unless otherwise contraindicated. Pharmaceutical Information for Ketorolac Tromethamine Injection Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications ~1 min read ▾

CONTRAINDICATIONS (see also BOXED WARNING ) Ketorolac Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. Ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactoid Reactions, and PRECAUTIONS – Pre-existing Asthma). Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion). Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ).

Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.

Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.

⚠️ Warnings ~3 min read ▾

WARNINGS (See also BOXED WARNING .) The total combined duration of use of oral ketorolac tromethamine and intravenous or intramuscular dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine is not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine are: • Gastrointestinal Effects – Risk of Ulceration, Bleeding and Perforation: Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or gastrointestinal (GI) bleeding.

Ketorolac tromethamine can cause serious GI adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with ketorolac tromethamine. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.

Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with ketorolac tromethamine. Do not use ketorolac tromethamine for more than five days.

However, even short-term therapy is not without risk. In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of ketorolac tromethamine until a serious GI adverse event is ruled out.

For high risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated. Hemorrhage Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet aggregation as well, use of ketorolac tromethamine in patients who have coagulation disorders should be undertaken very cautiously, and those patients should be carefully monitored.

Patients on therapeutic doses of anticoagulants (e.g., heparin or dicumarol derivatives) have an increased risk of bleeding complications if given ketorolac tromethamine concurrently; therefore, physicians should administer such concomitant therapy only extremely cautiously. The concurrent use of ketorolac tromethamine and therapy that affects hemostasis, including prophylactic low-dose heparin (2500-5000 units q12h), warfarin and dextrans have not been studied extensively, but may also be associated with an increased risk of bleeding.

Until data from such studies are available, physicians should carefully weigh the benefits against the risks, and use such concomitant therapy in these patients only extremely cautiously. Patients receiving therapy that affects hemostasis should be monitored closely. In postmarketing experience, postoperative hematomas and other signs of wound bleeding have been reported in association with the peri-operative use of intravenous or intramuscular dosing of ketorolac tromethamine.

Therefore, peri-operative use of ketorolac tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical (see PRECA…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see BOXED WARNING , WARNINGS , PRECAUTIONS , and DOSAGE & ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.

In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: * Incidence greater than 10% Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include: Body as a Whole: fever, infections, sepsis Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope Dermatologic: alopecia, photosensitivity, urticaria Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia Metabolic and Nutritional: weight change Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise Reproductive, female: infertility Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention Other rarely observed reactions (reported from postmarketing experience in patients taking ketorolac tromethamine or other NSAIDs) are: Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see WARNINGS ), myalgia Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease) Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, post operative wound hemorrhage (rarely requiring blood transfusion — see BOXED WARNING , WARNINGS , and PRECAUTIONS ) Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia Nervous System: aseptic meningitis, convulsions, coma, psychosis Respiratory: bronchospasm, respiratory depression, pneumonia Special Senses: conjunctivitis Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome Postmarketing Surveillance Study A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamine, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent (see Tables 3A and 3B).

This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine (see Table 3A). Table 3: Incidence of Clinically Serious G.I. Bleeding as Related to Age, Total Daily Dose, and History of G.I.

Perforation, Ulcer, Bleeding (PUB) after up to 5 Days of Treatment with Ketorolac Tromethamine Injection TABEL 1 TABEL 2

🆘 Overdosage 173 words ▾

OVERDOSAGE Symptoms and Signs Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.

Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Treatment Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes.

Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form.

Ketorolac tromethamine possesses no sedative or anxiolytic properties. The peak analgesic effect of ketorolac tromethamine occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of ketorolac tromethamine. The greatest difference between large and small doses of ketorolac tromethamine by either route is in the duration of analgesia.

Pharmacokinetics Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S‑form having analgesic activity. Comparison of Intravenous, Intramuscular and Oral Pharmacokinetics The pharmacokinetics of ketorolac tromethamine, following intravenous, intramuscular and oral doses of ketorolac tromethamine are compared in Table 1. In adults, the extent of bioavailability following administration of the ORAL and INTRAMUSCULAR forms of ketorolac tromethamine was equal to that following an intravenous bolus.

Table 1: Table of Approximate Average Pharmacokinetic Parameters (Mean±SD) Following Oral, Intramuscular and Intravenous Doses of Ketorolac Tromethamine Linear Kinetics In adults, following administration of single ORAL, INTRAMUSCULAR or INTRAVENOUS doses of ketorolac tromethamine in the recommended dosage ranges, the clearance of the racemate does not change. This implies that the pharmacokinetics of ketorolac tromethamine in adults, following single or multiple intramuscular, intravenous or recommended oral doses of ketorolac tromethamine, are linear.

At the higher recommended doses, there is a proportional increase in the concentrations of free and bound racemate. Distribution The mean apparent volume (Vβ) of ketorolac tromethamine following complete distribution was approximately 13 liters. This parameter was determined from single-dose data.

The ketorolac tromethamine racemate has been shown to be highly protein bound (99%). Nevertheless, plasma concentrations as high as 10 mcg/mL will only occupy approximately 5% of the albumin binding sites. Thus, the unbound fraction for each enantiomer will be constant over the therapeutic range.

A decrease in serum albumin, however, will result in increased free drug concentrations. Ketorolac tromethamine is excreted in human milk (see PRECAUTIONS – Nursing Mothers). Metabolism Ketorolac tromethamine is largely metabolized in the liver.

The metabolic products are hydroxylated and conjugated forms of the parent drug. The products of metabolism, and some unchanged drug, are excreted in the urine. Excretion The principal route of elimination of ketorolac and its metabolites is renal.

About 92% of a given dose is found in the urine, approximately 40% as metabolites and 60% as unchanged ketorolac. Approximately 6% of a dose is excreted in the feces. A single-dose study with 10 mg ketorolac tromethamine (n = 9) demonstrated that the S-enantiomer is cleared approximately two times faster than the R-enantiomer and that the clearance was independent of the route of administration.

This means that the ratio of S/R plasma concentrations decreases with time after each dose. There is little or no inversion of the R- to S- form in humans. The clearance of the racemate in normal subjects, elderly individuals and in hepatically and renally impaired patients is outlined in Table 2 (see CLINICAL PHARMACOLOGY – Kinetics in Special Populations).

The half-life of the ketorolac tromethamine S-enantiomer was approximately 2.5 hours (SD ± 0.4) compared with 5 hours (SD ± 1.7) for the R-enantiomer. In other studies, the half-life for the racemate has been reported to lie within the range of 5 to 6 hours. Accumu…

📦 How Supplied / Storage and Handling 146 words ▾

HOW SUPPLIED KETOROLAC TROMETHAMINE is supplied in the following dosage forms. NDC 51662-1292-1 KETOROLAC TROMETHAMINE INJ, USP 30mg/mL 1mL VIAL NDC 51662-1295-1 KETOROLAC TROMETHAMINE INJ, USP 60mg/2mL VIAL NDC 51662-1295-2 Pouch of 1 KETOROLAC TROMETHAMINE INJ, USP 60mg/2mL VIAL NDC 51662-1295-3 Case of 25 Pouches of KETOROLAC TROMETHAMINE INJ, USP 60mg/2mL VIAL NDC 51662-1292-2 Pouch of 1 KETOROLAC TROMETHAMINE INJ., USP 30mg/mL 1mL VIAL NDC 51662-1292-3 Case of 25 Pouches of KETOROLAC TROMETHAMINE INJ., USP 30mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ketorolac Tromethamine Injection, USP is supplied as follows: * FOR INTRAMUSCULAR USE ONLY.

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. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0894-1.0 Revised: 04/2018 TABEL LOGO

📋 Description 184 words ▾

DESCRIPTION Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine.

Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26.

The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol,USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water.

The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color. STRUCTURE

💬 Patient Medication Information ~3 min read ▾

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, • increasing doses of NSAIDs or stomach or intestinal • longer use of NSAIDs bleeding with the use of • smoking NSAIDs • drinking alcohol • taking medicines called • older age "corticosteroids", • poor health "anticoagulants", "SSRIs", or • advanced liver disease "SNRIs" • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems • have high blood pressure • have asthma • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. • are breastfeeding or plan to breast feed Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements.

NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including: See "What is the most important information I should know about medicines called NonSteroidal Anti-inflammatory Drugs (NSAIDs)?" • new or worse high blood pressure • heart failure • liver problems including liver failure • kidney problems including kidney failure • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: • shortness of breath or trouble breathing • chest pain • weakness in one part or side of your body • slurred speech • swelling of the face or throat Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: • nausea • vomit blood • more tired or weaker than usual • there is blood in your bowel movement • diarrhea or it is black and sticky like tar • itching • unusual weight gain • your skin or eyes look yellow • skin rash or blisters with fever • indigestion or stomach pain • swelling of the arms and legs, hands and • flu-like symptoms feet If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the p…

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
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 HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 25 pouches (51662-1292-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1885 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 51662-1291-01 · HF 51662-1293-01 · HF →
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.