Alphanine Kit
Product Images NDC 68516-3609

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Alphanine (NDC 68516-3609). 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

3058363vial500iu10ml

AlphaNine SD Coagulation Factor IX (Human) 500 IU FIX Range kit label by Grifols USA, LLC. The label indicates a solvent detergent treated and virus filtered 10 mL storage vial to be kept between 2 and 8 °C, with allowance for storage up to 30 °C for one month. It instructs reconstitution with 10 mL sterile water for injection and emphasizes single-dose use for intravenous administration only.*

FDA Label Image

3058364carton500iu10ml

AlphaNine SD Coagulation Factor IX (Human) 10 mL kit packaging label with 500 IU FIX range. The label indicates the product is solvent detergent treated and virus filtered, intended for intravenous administration. It is labeled by Grifols USA, LLC, and includes storage, usage, and warning information.*

FDA Label Image

3058365vial1000iu10ml

Label for AlphaNine SD Coagulation Factor IX (Human) kit by Grifols USA, LLC. The label shows the product name with 1000 IU FIX range, solvent detergent treated 10 mL vial, storage conditions between 2 and 8°C with specified room temperature allowance, and administration route intravenous. It includes manufacturer address and dosing instructions alongside a barcode and space for lot and expiration dates.*

FDA Label Image

3058365vial1500iu10ml

Label for AlphaNine SD 1500 IU FIX Range, a plasma derivative kit containing Coagulation Factor IX (Human) for intravenous use. The label indicates the product is solvent detergent treated and virus filtered, supplied in a 10 mL form. Storage instructions specify 2 to 8 °C, with a one-month allowance at room temperature not exceeding 30 °C. The label includes regulatory information, manufacturer details for Grifols Biologicals LLC, and a barcode.*

FDA Label Image

3058367carton1000iu10ml

Packaging label for AlphaNine SD Coagulation Factor IX (Human) 10 mL kit by Grifols USA, LLC. The label states the product is a plasma derivative for intravenous administration, solvent detergent treated and virus filtered. It indicates a 1000 IU factor IX activity range. The label includes contents, warnings, storage instructions, and manufacturer information.*

FDA Label Image

3058369carton1500iu10ml

Label for AlphaNine SD, Coagulation Factor IX (Human) 10 mL kit by Grifols USA, LLC. The product is a plasma derivative prepared as solvent detergent treated and virus filtered, indicated for intravenous administration. The label includes dosage strength of 1500 IU FIX Range and storage, warnings, and instructions information on the side panel.*

FDA Label Image

Sterilewaterlabel

Label for Sterile Water for Injection, USP, 10 mL single-dose container. The label indicates it is nonpyrogenic and intended for reconstitution of an accompanying product, with instructions about use. Manufactured by Laboratorios Grifols, S.A., Parets del Vallès, Barcelona, Spain. Includes NDC 76297-002-12.*

FDA Label Image

Sterilewaterlabel2

Label for Sterile Water for Injection, USP, 10 mL single-dose container. It is for reconstitution of an accompanying product, nonpyrogenic, without antimicrobial agents. Manufactured by Laboratorios Grifols, S.A. in Barcelona, Spain, and labeled for Grifols Biologicals LLC, Los Angeles, CA, USA.*

FDA Label Image

Figure (Alp02 0008 01)

A data table illustrating body weight in kilograms with an example of 70 kg, desired increase in plasma Factor IX percentage with an example of 40%, and the calculation of the number of Factor IX units required, shown as 2,800 IU AlphaNine SD.*

FDA Label Image

Figures 1-8 (Alp02 0008 02)

An illustrated step-by-step diagram demonstrating the reconstitution process for the AlphaNine SD kit, a plasma derivative containing Coagulation Factor IX (Human). The images depict how to attach dissolvent vials to the product vial, mix by swirling, and prepare the solution for intravenous administration.*

* 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.