Ketorolac Tromethamine Injection, Solution
Product Images NDC 0404-9998

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ketorolac Tromethamine (NDC 0404-9998). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Henry Schein, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

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Chemical structure of Ketorolac tromethamine, showing the ketorolac moiety bonded to tromethamine. The diagram illustrates the molecular components, including a benzoyl group, a pyrrolizine ring, a carboxyl group, and the tromethamine component with three hydroxymethyl groups.*

FDA Label Image

Image1.jpg (Image1)

A data table presenting approximate average pharmacokinetic parameters with mean and standard deviation for Ketorolac Tromethamine following oral, intramuscular, and intravenous doses. Parameters include Tmax, Cmax, Cmin, Cavg, bioavailability, and volume of distribution (Vbeta) across different dosage strengths and administration routes.*

FDA Label Image

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A data table presenting pharmacokinetic parameters for Ketorolac Tromethamine, including percentages of dose metabolized, excreted in feces and urine, and plasma protein binding. It also includes notes referencing derivation of data from oral, intramuscular, and intravenous pharmacokinetic studies, and relevant pharmacokinetic terms such as time-to-peak plasma concentration and volume of distribution.*

FDA Label Image

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A data table titled 'The Influence of Age, Liver and Kidney Function, on the Clearance and Terminal Half-life of Ketorolac Tromethamine (Intramuscular and Oral) in Adult Populations.' It presents total clearance (in L/h/kg) and terminal half-life (in hours) for various subject groups including normal subjects, healthy elderly, hepatic dysfunction patients, renal impairment patients, and renal dialysis patients, comparing intramuscular and oral administration.*

FDA Label Image

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A table listing gastrointestinal (GI) and other adverse experiences including abdominal pain, constipation/diarrhea, dyspepsia, flatulence, GI fullness, GI ulcers, gross bleeding/perforation, heartburn, nausea, stomatitis, vomiting, abnormal renal function, anemia, dizziness, drowsiness, edema, elevated liver enzymes, headaches, hypertension, increased bleeding time, injection site pain, pruritus, purpura, rashes, tinnitus, and sweating.*

FDA Label Image

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Data table presenting the incidence of clinically serious gastrointestinal bleeding related to age, total daily dose, and history of GI perforation, ulcer, or bleeding (PUB) after up to 5 days of treatment with Ketorolac Tromethamine Injection. The table divides data into adult patients without and with a history of PUB, showing percentages across different total daily dose ranges and age groups.*

FDA Label Image

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A data table listing NDC numbers, Ketorolac Tromethamine Injection USP strengths and vial sizes, and package factors. It details three product options: 15 mg/mL in a 1 mL single-dose vial, 30 mg/mL in a 1 mL single-dose vial, and 60 mg/2 mL in a 2 mL single-dose vial, each packaged as 25 vials per carton.*

FDA Label Image

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Label for Ketorolac Tromethamine 15 mg/mL injection, solution in a single-dose 1 mL vial. Label indicates use for intramuscular or intravenous administration and includes storage instructions, lot number, expiration date placeholder, and labeler information for Henry Schein, Inc., located in Bastian, VA.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.