Koate Kit
Product Images NDC 76125-676

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Koate (NDC 76125-676). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kedrion Biopharma, 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

13533 000 04

Label for Sterile Water for Injection, USP, 5 mL single-dose container, nonpyrogenic, used for reconstitution of accompanying product. Manufactured by Baxter Healthcare Corporation and Mfd for Grifols Therapeutics LLC. Marked for placement only with areas for lot and expiration date.*

FDA Label Image

13533 200 05

Label of a 5 mL vial of Sterile Water for Injection, USP, intended for reconstitution of an accompanying product. The label includes usage instructions, cautions about clarity and microbial content, and manufacturer information: Laboratorios Grifols, S.A. in Spain and Grifols Therapeutics LLC in the USA.*

FDA Label Image

Label 76125-252-21 (76125 252 21)

Koate Antihemophilic Factor (Human) kit label with solvent/detergent treated, heat-treated at 80°C. Manufactured by Kedrion Biopharma Inc. and Grifols Therapeutics LLC. The label includes storage instructions, reconstitution guidance with sterile water, and usage notes for intravenous administration. Lot, expiration date, and identification codes are visible.*

FDA Label Image

76125 256 20

Packaging label for Koate Antihemophilic Factor (Human) 250 IU vial range, a plasma derivative intravenous kit by Kedrion Biopharma, Inc. The label includes product name, concentration, 5 mL volume, solvent/detergent treated and heat-treated at 80°C. It features warnings, storage instructions, contents list including sterile water and filter transfer set, and manufacturer details.*

FDA Label Image

76125 668 30

Packaging label for Koate Antihemophilic Factor (Human) 5 mL Kit, a plasma derivative for intravenous use. The label indicates the product is solvent/detergent treated and heat-treated at 80°C. It is manufactured by Kedrion Biopharma, Inc. The label includes dosage form details, storage instructions, caution warnings, and contents listing for a 5 mL sterile water injection and one sterile transfer set. The product is Rx only.*

FDA Label Image

Label 76125-669-31 (76125 669 31)

Label for Koate Antihemophilic Factor (Human) plasma derivative kit for intravenous use. The product is solvent/detergent treated and heat-treated at 80°C. Label shows NDC 76125-669-31, manufactured for Kedrion Biopharma Inc., Fort Lee, NJ, and manufactured by Grifols Therapeutics LLC, North Carolina. Includes storage and administration notes such as sterile, nonpyrogenic, and storage instructions.*

FDA Label Image

Label 76125-673-51 (76125 673 51)

Label for Koate Antihemmophilic Factor (Human) kit, a plasma derivative for intravenous administration. The label includes manufacturer information (Kedrion Biopharma Inc. and Grifols Therapeutics LLC), storage instructions, and reconstitution details. It specifies solvent/detergent treatment and heat treatment at 80°C, with no preservatives and a note to read the package insert for dosage and administration.*

FDA Label Image

76125 676 50

Label for Koate Antihemophilic Factor (Human) 10 mL intravenous kit by Kedrion Biopharma, Inc. The label shows the product as solvent/detergent treated and heat-treated at 80°C. It includes storage warnings, preparation instructions, and content details including one bottle of Koate and sterile water for injection. The label also includes a barcode and NDC 76125-676-50.*

FDA Label Image

76297 002 02

Label for Sterile Water for Injection, USP, 5 mL single-dose vial. The label highlights use for reconstitution, with instructions indicating it is nonpyrogenic and should be used only if clear, without added antimicrobial agents. Manufactured by Laboratorios Grifols in Spain, it is for intravenous use and Rx only.*

FDA Label Image

Figures 1-8 (Figs1to8)

An instructional diagram showing eight sequential figures illustrating the steps to prepare and administer a medication kit. The figures depict connecting diluent and product vials, mixing them, inverting the vials, and drawing the solution into a syringe, highlighting the proper technique for intravenous preparation and use.*

* 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.