Profilnine Kit
Product Images NDC 68516-3212

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Profilnine (NDC 68516-3212). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Grifols Usa, Llc, 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

10mlsterilewaterlabel

Sterile Water for Injection, USP in a 10 mL single-dose container, used for reconstitution of an accompanying product. Label notes the container is nonpyrogenic and no antimicrobial agent is added. Manufactured by Laboratorios Grifols, S.A. in Barcelona, Spain. The label includes NDC 76297-002-12 and is marked Rx only.*

FDA Label Image

3210carton5ml500iu

Profilnine Factor IX Complex 5 mL vial packaging label showing a 500 IU FIX range. The label is from GRIFOLS USA, LLC, indicating it is for intravenous administration. The packaging includes warnings, storage instructions, and directions for use along with the NDC code 68516-3210-1.*

FDA Label Image

3211carton10ml1000iu

Profilnine Factor IX Complex packaging label by GRIFOLS USA, LLC. The label indicates a 10 mL vial with 1000 IU FIX Range for intravenous administration. The label features product contents, usage instructions, storage conditions, warnings, and barcode information, all presented with a blue, white, and red color scheme.*

FDA Label Image

3211carton10ml1500iu

Profilnine Factor IX Complex packaging label by GRIFOLS USA, LLC showing 10 mL vial size with a dosage range of 1500 IU FIX. The label includes storage instructions, warnings, contents, and administration guidelines for intravenous use. Branding and serial barcodes are visible.*

FDA Label Image

5mlsterilewaterlabel

Label of Sterile Water for Injection, USP, 5 mL single-dose container for reconstitution use. Marked Rx Only, with instructions emphasizing it is nonpyrogenic and does not contain antimicrobial agents. Manufactured by Laboratorios Grifols, S.A., Barcelona, Spain, under NDC 76297-002-02. Intended as diluent for an accompanying product.*

FDA Label Image

68516 1001 Label

Label for Sterile Water for Injection, USP, 5 mL single-dose container. The label states it is for reconstitution of an accompanying product, nonpyrogenic, and includes usage instructions and manufacturer details: produced by Laboratorios Grifols, S. A. in Spain and labeled for Grifols Biologicals LLC, Los Angeles, CA.*

FDA Label Image

68516 1002 2diluent

Profilnine Sterile Water for Injection, USP, 10 mL single-dose container label. The label indicates it is for reconstitution of an accompanying product, nonpyrogenic, with instructions for proper use. Manufactured by Laboratorios Grifols, S.A. in Barcelona, Spain, and labeled for Grifols Biologicals Inc., Los Angeles, CA, USA.*

FDA Label Image

68516-3204-1-profilnine-500-iu (68516 3204 1 Label)

Profilnine 500 IU FIX Range Factor IX Complex label from Grifols Biologicals LLC. The label specifies a 5 mL single-dose container for intravenous administration, with storage instructions to keep below 25 °C (77 °F). It includes detailed administration and disposal instructions and identifies Grifols Biologicals LLC, Los Angeles, CA as the labeler.*

FDA Label Image

68516-3205-2-profilnine-1000-iu (68516 3205 2 Label)

Profilnine Factor IX Complex 1000 IU FIX Range injectable solution label from GRIFOLS USA, LLC. The 10 mL vial label includes storage instructions to keep below 25°C and usage as a single dose container for intravenous administration. The label also provides manufacturer details and reconstitution instructions with sterile water.*

FDA Label Image

68516-3206-2-profilnine-1500-iu (68516 3206 2 Label)

Profilnine Factor IX Complex 1500 IU FIX Range label shows a 10 mL single-dose vial for intravenous administration. The label includes storage instructions (store at temperatures not exceeding 25°C), the labeler GRIFOLS USA, LLC, and instructions for reconstitution with sterile water. It also displays the NDC 68516-3206-2 and regulatory information including Rx only and license details.*

FDA Label Image

Figures 1-8 (Pro00 0010 01)

An instructional diagram illustrating eight sequential steps for preparing a product using a vial and diluent system. The images depict connecting and mixing the diluent with the product vial, culminating in drawing the reconstituted solution into a syringe. Each step is clearly numbered and visually guides the preparation process.*

* 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.