Koate Kit
Product Images NDC 76125-665

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Koate (NDC 76125-665). 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

13533 000 04
This is a description for a single-dose container of sterile water for injection, with a volume of 5ml. It is nonpyrogenic and is intended for reconstitution of another product. It is not to be used for intravascular injection unless made approximately isotonic by adding a suitable diluent. The container has been manufactured for Grifols Therapeutics LLC by Baxter Healthcare Corporation. Rx Only.*
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13533 200 05

13533 200 05
This is a label from a container of sterile water for injection, which is intended for use in accompanying products that require reconstitution. The container is for single use only and should not be used if the solution is not clear. It does not contain any antimicrobial agent or other substances. If used for intravascular injection, a suitable solute should be added to make the solution close to isotonic. Any unused portion should be discarded. The product is manufactured by Laboratorios Grifols in Spain and distributed by Grifols Therapeutics in the USA. The item is identified by a lot number and expiration date, as well as the NDC code 13533-200-05.*
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Label 76125-252-21 (76125 252 21)

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76125 256 20

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76125 668 30

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Label 76125-669-31 (76125 669 31)

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Label 76125-673-51 (76125 673 51)

Label 76125-673-51 (76125 673 51)
This is a product description for Koate Antihemophilic Factor (Human), which is a medication used for intravenous administration. It is heat-treated and solvent/detergent treated for safety, and it is manufactured by Grifols Therapeutics LLC. The medication is stored in a cold environment and should be reconstituted with sterile water for injection before use. Dosage and administration instructions are included in the package insert, and the risks and benefits of the medication should be discussed with a physician. There is no preservative in the medication, and it is sterile and nonpyrogenic. The lot number is 3051812, and the expiration date should be checked before using.*
FDA Label Image

76125 676 50

76125 676 50
The text appears to be a short string of letters and the name of a medicinal product "Koate" with the indication of "Antihemophilic Factor (Human)". It is likely to be the name of a medication used for the treatment of hemophilia, a genetic bleeding disorder.*
FDA Label Image

76297 002 02

76297 002 02
This is a description of Sterile Water for Injection, USP, which is a nonpyrogenic, single-use container used to reconstitute other products. The container does not contain any antimicrobial agents or other substances and should only be used for intravascular injection after being made approximately isotonic by the addition of a suitable solute. Any unused portions should be discarded. The manufacturer is Laboratorios Grifls, S, A. located in Barcelona, Spain. The NDC number for this product is 76297-002-02.*
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Figures 1-8 (Figs1to8)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.