Alphanate Kit
Product Images NDC 68516-4616

15 FDA label images from Grifols Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Alphanate (NDC 68516-4616). 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

10ml1500iucartonlablel

10ml1500iucartonlablel
Carton label for Alphanate, an antihemophilic factor/von Willebrand factor complex (human) manufactured by GRIFOLS. The label indicates a 10 mL vial with a 1500 IU FVIII range, solvent detergent/heat treated, for intravenous administration. Additional label information includes composition details, warnings, storage instructions, and manufacturer contact.*
FDA Label Image

10mlsterilewaterlablel

10mlsterilewaterlablel
Label for Sterile Water for Injection, USP, 10 mL single-dose container for reconstitution of accompanying product. Manufactured by Laboratorios Grifols, S.A., Barcelona, Spain. Contains usage warnings and storage instructions, includes barcode and QR code.*
FDA Label Image

10mll1000iucartonlablel

10mll1000iucartonlablel
Packaging label for Alphanate, an Antihemophilic Factor/von Willebrand Factor Complex (Human) by GRIFOLS USA, LLC. The label indicates 10 mL vial size, 1000 IU FVIII range, solvent detergent/heat treated, and is for intravenous administration. The label includes warnings, instructions, storage conditions, and manufacturer information.*
FDA Label Image

10mll1000iuviallablel

10mll1000iuviallablel
Alphanate label from Grifols USA, LLC for Antihemophilic Factor/von Willebrand Factor Complex (Human) with a strength of 1000 IU FVIII Range, solvent detergent and heat treated, 10 mL vial. The label includes storage instructions to keep at temperatures not exceeding 25°C (77°F) and specifies it is for single dose intravenous administration only.*
FDA Label Image

10mll1500iuviallablel

10mll1500iuviallablel
Label for Alphanate, an antihemophilic factor/von Willebrand factor complex (human), in a 10 mL vial with 1500 IU FVIII range. The label includes storage instructions to keep at temperatures not exceeding 25°C, single dose intravenous use, and is from Grifols USA, LLC, located in Los Angeles, CA. The label also features the NDC number 68516-4608-2 and barcode.*
FDA Label Image

10mll2000iucartonlablel

10mll2000iucartonlablel
Packaging label for Alphanate, an antihemophilic factor/von Willebrand factor complex (human) by GRIFOLS. The vial contains 10 mL with a potency of 2000 IU FVIII Range. Label indicates the product is solvent detergent/heat treated and intended for intravenous administration. Manufacturer information for Grifols Biologicals LLC in Los Angeles, CA, is also shown with storage and usage instructions.*
FDA Label Image

10mll2000iuviallablel

10mll2000iuviallablel
Label for Alphanate, an Antihemophilic Factor/von Willebrand Factor Complex (Human) in a 10 mL vial. The label indicates a strength range of 2000 IU FVIII. It is heat treated and contains solvent detergent. Storage instructions specify temperatures not exceeding 25 °C. The product is labeled for single dose intravenous use. Manufacturer information lists Grifols Biologicals LLC, Los Angeles, CA, USA.*
FDA Label Image

5mlsterilewaterlablel

5mlsterilewaterlablel
Label for Sterile Water for Injection, USP, 5 mL single-dose container. The label states it is nonpyrogenic and for reconstitution of an accompanying product only. Manufactured by Laboratorios Grifols, S. A., Barcelona, Spain. Contains usage warnings including not for intravascular injection unless made isotonic. Rx only.*
FDA Label Image

5mll250iucartonlablel

5mll250iucartonlablel
Label for Alphanate 250 IU FVIII Range, an Antihemophilic Factor/von Willebrand Factor Complex (Human) by GRIFOLS USA, LLC. The label indicates a 5 mL vial for intravenous administration, solvent detergent heat treated. Contains usage instructions, warnings, storage, and manufacturer information. Barcode and QR code also present on the packaging.*
FDA Label Image

5mll250iuviallablel

5mll250iuviallablel
Label for Alphanate, an Antihemophilic Factor/von Willebrand Factor Complex (Human), 5 mL vial with 250 IU FVIII Range strength. The label indicates it is solvent detergent/heat treated, for intravenous single-dose use, and must be stored at temperatures not exceeding 25°C. Manufactured by Grifols Biologicals LLC, Los Angeles, CA, and labeled by GRIFOLS USA, LLC.*
FDA Label Image

5mll500iucartonlablel

5mll500iucartonlablel
Packaging label for Alphanate, an Antihemophilic Factor/von Willebrand Factor Complex (Human) by GRIFOLS USA, LLC. The label indicates a 5 mL vial containing 500 IU FVIII Range, for intravenous administration. The product is solvent detergent/heat treated and includes instructions, storage information, and warnings on the label.*
FDA Label Image

5mll500iuviallablel

5mll500iuviallablel
Label for Alphanate, Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate by Grifols USA, LLC. The label indicates a 5 mL solution vial with 500 IU FVIII range strength, heat-treated and solvent detergent purified. It includes storage instructions and usage limitations, specifying single dose use for intravenous administration only.*
FDA Label Image

68516 1001

68516 1001
Packaging label of Sterile Water for Injection, USP in a 5 mL single-dose container. The label states it is for reconstitution of an accompanying product, nonpyrogenic, and manufactured by Laboratorios Grifols, S.A., Spain, for Grifols Biologicals LLC, USA. It includes usage warnings and batch identification.*
FDA Label Image

68516 1002

68516 1002
Label of Alphanate sterile water for injection, USP presented in a 10 mL single-dose container. The label includes usage instructions for reconstitution of the accompanying product, manufacturing details by Laboratorios Grifols, S.A. in Spain, and Grifols Biologicals LLC in the USA. It specifies the product is nonpyrogenic and for Rx use only.*
FDA Label Image

Figures 1-8 (Alp03 0009 01)

Figures 1-8 (Alp03 0009 01)
An instructional diagram showing eight sequential figures illustrating the steps to prepare and transfer diluent and product between containers, likely for reconstitution or administration purposes. The images depict connecting, inverting, and mixing actions between a diluent container and a product vial.*

* 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.