Recombinate Kit
Product Images NDC 0944-2843

Product Visual Gallery

This gallery contains 25 technical images submitted to the FDA as part of the official labeling for Recombinate (NDC 0944-2843). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Takeda Pharmaceuticals America, 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

Recombinate 01

Recombinate packaging label with two clear glass vials and a plastic measuring device. The image shows the product box and container components, labeled by Baxalta US Inc. Specific strength, dosage form, and count are not visible in the image.*

FDA Label Image

Recombinate 02

A data table showing color-coded dosage strength ranges for Recombinate per vial. Light-blue corresponds to approximately 250 IU (220-400 IU/vial), pink to 500 IU (401-800 IU/vial), green to 1000 IU (801-1240 IU/vial), purple to 1500 IU (1241-1800 IU/vial), and orange to 2000 IU (1801-2400 IU/vial).*

FDA Label Image

Recombinate 03

Recombinate packaging showing two glass vials and a plastic mixing device. The image includes a box likely used for packaging the product. The labeler is Baxalta US Inc. The image suggests a sterile injectable drug product in vial form with a mixing accessory.*

FDA Label Image

Recombinate 04

An illustration showing a gloved hand holding a vial labeled Recombinate. The image indicates peeling off the vial cap, represented by an arrow pointing to the cap being removed from the vial.*

FDA Label Image

Recombinate 05

An illustration showing two stages of drug preparation in vials. The left vial contains a dry powder, and the right vial is being reconstituted with a liquid, creating a dissolved solution. A hand is holding the liquid container above the vial on the right, depicting the mixing process.*

FDA Label Image

Recombinate 06

An instructional illustration showing the partially peeled back protective outer cover of a medical device component, revealing a blue and white inner mechanism. A black arrow indicates the direction to peel the cover for device access or use.*

FDA Label Image

Recombinate 07

An instructional diagram showing how to attach a clear plastic cap with a blue tab onto a vial containing a liquid. The steps demonstrate positioning the cap above the vial and pressing it down to secure it, with arrows indicating the direction of movement.*

FDA Label Image

Recombinate 08

An instructional diagram showing the assembly of a Recombinate vial transfer set. The illustration depicts attaching a transfer device from a vial containing a blue liquid to an empty vial below, indicated by a downward arrow, demonstrating how to connect the components for solution transfer.*

FDA Label Image

Recombinate 09

An instructional diagram showing a step in the use or assembly of a medical device related to Recombinate by Baxalta US Inc. The illustration depicts a bottle or vial with an attached component and a blue clip, indicating a mechanism for transferring or accessing the drug product.*

FDA Label Image

Recombinate 10

An instructional illustration showing steps to use a medical vial and syringe. Step 1 indicates removing or attaching a component at the vial top. Step 2 depicts drawing liquid from the vial into the syringe by pulling back the plunger with a twisting motion.*

FDA Label Image

Recombinate 11

An instructional illustration showing the process of drawing fluid from an upside-down vial into a syringe. The vial contains a blue liquid, and the syringe is positioned horizontally with the needle inserted into the vial's stopper, indicated by a black arrow pointing to the right.*

FDA Label Image

Recombinate 12

An illustration showing a gloved hand applying a small adhesive patch or dressing to the inner forearm of a person. The image depicts a step in medication administration or wound care, highlighting the placement of the patch on the skin.*

FDA Label Image

Recombinate 13

An illustrated instructional diagram showing an intravenous (IV) procedure on a person's arm. The image depicts a medical professional's gloved hands holding an IV syringe connected by tubing to a needle inserted into a vein in the patient's arm.*

FDA Label Image

Recombinate 14

An illustration showing two hands holding a vial with an unreadable label over a blurred background that appears to be a medication information sheet. The vial is clear with a gray cap.*

FDA Label Image

Recombinate 15

Label for 5 mL Sterile Water for Injection, USP by Baxalta US Inc., intended for reconstitution of accompanying product. Label includes usage instructions, cautions, and dosage form as single dose container, nonpyrogenic. The label also shows NDC 52919-003-08 and manufacturing information.*

FDA Label Image

Recombinate 16

Recombinate label showing antihemophilic factor (recombinant) for intravenous administration. It includes storage instructions, lot number, expiration date, date and time of dose fields, and manufacturer information for Baxalta US Inc. The label states no preservative and indicates Rx only.*

FDA Label Image

Recombinate 17

Recombinate (Antihemophilic Factor [Recombinant]) packaging label from Baxalta US Inc. for a single-use vial. The label includes storage instructions, patient notification contact, contents description including 5 mL sterile water and stabilizing agents, and directions for intravenous administration. The label also features trademarks and manufacturer information and the NDC code 0944-2841-10.*

FDA Label Image

Recombinate 18

Label for Recombinate, an antihemophilic factor (recombinant) manufactured by Baxalta US Inc. The label includes fields for FVIII IU per vial, lot number, expiration date, and dose timing. Storage instructions specify refrigeration at 36° to 46°F or room temperature up to 86°F after reconstitution, with no preservative. The label also states it is for intravenous administration only and Rx use only.*

FDA Label Image

Recombinate 19

Recombinate Antihemmophilic Factor (Recombinant) packaging label by Baxalta US Inc. The label includes storage instructions, single-use vial info, directions for intravenous use, patient notification system contact, and contents including one vial of 5 mL antihemophilic factor with stabilizing agents. The label indicates no coating on the vial and provides manufacturer details and regulatory information.*

FDA Label Image

Recombinate 20

Recombinate label from Baxalta US Inc. showing the product name with antihemophilic factor (recombinant) designation. It includes spaces for vial-specific information like FVIII IU per vial, lot number, expiration date, and dose date/time. Instructions note intravenous administration, storage conditions, and absence of preservative. The label also references the package insert for directions.*

FDA Label Image

Recombinate 21

Recombinate packaging label for Antihemophilic Factor (Recombinant) by Baxalta US Inc. The label shows a single-use vial with 5 mL volume, includes BAXJECT II Needleless Transfer Device, and storage instructions: refrigerate at 36° to 46°F or store at room temperature up to 86°F, do not freeze. The label also provides caution for intravenous administration only and directions to read the package insert. The product contains stabilizing agents and lists a U.S. License number and code 1502737.*

FDA Label Image

Recombinate 22

Recombinate label for antihemophilic factor (recombinant) manufactured by Baxalta US Inc. The label includes dosage information (FVIII IU/vial), storage instructions, lot number, expiration date, and dosage administration time fields. It specifies intravenous use, no preservative content, and refrigeration storage with temperature instructions. The NDC number 0944-2834-01 is visible.*

FDA Label Image

Recombinate 23

Recombinate packaging label for Antihemophilic Factor (Recombinant) by Baxalta US Inc. The label indicates a single-use vial including BAXJECT II Needleless Transfer Device, with storage instructions at 36° to 46°F and up to 86°F. It includes warnings "NO COAT" and directions for intravenous administration only, with a note to read the package insert for full directions. The label details contents and stabilizing agents, patient notification system contact, and manufacturer information from Lexington, MA, USA.*

FDA Label Image

Recombinate 24

Packaging label for Recombinate, an antihemophilic factor (recombinant) by Baxalta US Inc. The label includes spaces to record FVIII IU per vial, lot number, expiration date, date and time of dose administration. It indicates storage instructions, intravenous administration only, and absence of preservatives. The label also displays the NDC 0944-2835-01 and emphasizes prescription use only.*

FDA Label Image

Recombinate 25

Recombinate (Antihemophilic Factor [Recombinant]) single-use vial packaging label from Baxalta US Inc. The label includes storage instructions to refrigerate between 36 to 46°F or store at room temperature up to 86°F, specifies that it should not be frozen, and mentions inclusion of a BAXJECT II Needleless Transfer Device. The label also notes the product is for intravenous use only and includes directions to read the package insert. Additional information covers patient and physician discussion of risks and benefits, as well as ingredients and stabilizing agents present after reconstitution.*

* 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.