Hadlima Solution
Product Images NDC 78206-185

Product Visual Gallery

This gallery contains 71 technical images submitted to the FDA as part of the official labeling for Hadlima (NDC 78206-185). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Organon 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.

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Figure 1 (Image 01)

A line graph showing the percentage of ACR20 responders over time in weeks for two groups: one receiving 40 mg of Hadlima (adalimumab-bwwd) every other week and one receiving a placebo. The x-axis represents time in weeks, while the y-axis indicates the percent of responders. The Hadlima group shows a marked increase in responders compared to the placebo group throughout the study period.*

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Figure 2 (Image 02)

A line graph depicting percentage of ASAS 20 response over 24 weeks comparing adalimumab (N=208) and placebo (N=107). The y-axis represents % ASAS 20 response ranging from 0 to 70%, and the x-axis shows time in weeks from 0 to 24. The adalimumab group shows a higher and sustained response compared to placebo over the study duration.*

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Samsung Logo (Image 03)

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Organon Logo (Image 04)

A product label panel indicating that the drug is manufactured for Organon LLC, a subsidiary of Organon & Co., located in Jersey City, NJ 07302, USA.*

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Samsung Logo (Image 05)

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Organon Logo (Image 06)

The image shows a product label stating the medication Hadlima (adalimumab-bwwd) is manufactured for Organon LLC, a subsidiary of Organon & Co., located in Jersey City, NJ, USA. The label does not show additional dosage or packaging details.*

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Figure A (Prefilled Syringe)

Illustration showing parts of a prefilled syringe for subcutaneous injection, labeled as needle cap, body with window, flange, and plunger. This diagram is related to the administration device for Hadlima (adalimumab-bwwd) solution.*

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Refrigerator (Image 08)

Hadlima 40 mg/0.4 mL solution for subcutaneous injection in a cartridge. The label includes the product name, strength, dosage form, and route. The labeler is Organon LLC. The cartridge shows dosage markings and fill volume indication.*

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Light (Image 09)

Hadlima 40 mg/0.8 mL solution for subcutaneous injection blister packaging. The label shows individual blister packs containing prefilled syringes. The product is a human prescription drug by Organon LLC, available in the strength of 40 mg/0.8 mL.*

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Caution (Image 10)

Hadlima 40 mg/0.4 mL solution for subcutaneous injection carton from Organon LLC. The packaging shows the product name, strength, and dosage form. The container count is not visible.*

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Container (Image 11)

Hadlima 40 mg/.4 mL solution for subcutaneous injection vial carton. The label shows the brand name Hadlima with the generic name adalimumab-bwwd. It is manufactured by Organon LLC. The packaging is designed for a single-dose vial containing 40 mg of medication in 0.4 mL solution.*

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Figure B (Prefilled Syringe)

An illustration showing a left hand wearing a pink watch with its face displaying time, positioned near a syringe with its plunger partially depressed. This figure likely relates to timing or administration instructions for a subcutaneous injection.*

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Figure C (Prefilled Syringe)

An illustrated instructional image depicting a prefilled syringe alongside an alcohol swab packet, a red sharps container labeled "Sharps Container," and several cotton balls or gauze pads. The image is titled "Figure C" and demonstrates items commonly used for subcutaneous injection preparation and disposal.*

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Figure D (Prefilled Syringe)

Illustration showing a hand holding a syringe filled with Hadlima (adalimumab-bwwd) solution, with a focus on inspecting the syringe contents. It highlights checking that the solution is clear, free of particles, and verifying the expiration date before use.*

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Figure E (Prefilled Syringe)

An instructional illustration showing recommended sites for subcutaneous injection on the front torso and upper thighs of a human figure, accompanied by a reminder to clean skin with an alcohol swab labeled '70% Isopropyl' before injection.*

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Figure F (Prefilled Syringe)

An instructional illustration showing hands removing the cap from a prefilled syringe, part of Hadlima (adalimumab-bwwd) subcutaneous solution administration steps.*

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Figure G (Prefilled Syringe)

An instructional illustration showing the proper technique for subcutaneous injection of Hadlima (adalimumab-bwwd) solution using a syringe, demonstrating holding the syringe at a 45-degree angle to the skin.*

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Figure H (Prefilled Syringe)

An illustration showing a hand holding a prefilled syringe used for subcutaneous injection, with an arrow indicating the pressing of the syringe plunger. Another hand is positioned to receive the injection, demonstrating proper injection technique.*

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Figure I (Prefilled Syringe)

An instructional illustration showing a hand holding a syringe with the needle retracted, alongside a sharps container. Text indicates confirmation criteria for completing a dose: needle retracted and no medicine leaked out (a small drop is acceptable). A circular close-up highlights the syringe's needle safety feature.*

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Samsung Logo (Image 20)

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Organon Logo (Image 21)

The image shows a portion of a packaging label stating that the product Hadlima (adalimumab-bwwd) solution is manufactured for Organon LLC, a subsidiary of Organon & Co., located in Jersey City, NJ, USA.*

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Figure A (Autoinjector)

Illustration labeled Figure A showing a prefilled syringe of Hadlima (adalimumab-bwwd) solution for subcutaneous injection. The diagram highlights the syringe components including the needle cap, base, medicine window, and medicine label area.*

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Refrigerator (Image 23)

Hadlima 40 mg/0.8 mL subcutaneous solution carton by Organon LLC. The packaging is mainly white with blue accents, featuring the product name and dosage strength prominently on the front. The label includes the active ingredient adalimumab-bwwd and other regulatory and identification details.*

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Light (Image 24)

Hadlima 40 mg/0.8 mL solution for subcutaneous injection carton, displaying the brand name, dosage strength, and the labeler Organon LLC on a predominantly white and blue box.*

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Caution (Image 25)

Hadlima 40 mg/0.8 mL subcutaneous solution vial label by Organon LLC. The label displays the proprietary and generic names, dosage strength, and route of administration specific to this human prescription drug.*

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Container (Image 26)

Hadlima 40 mg/0.8 mL solution for subcutaneous injection carton and vial label. The packaging displays the brand name Hadlima prominently, with the generic name adalimumab-bwwd noted. The product is presented as a 0.8 mL solution containing 40 mg of active ingredient. The labeler is Organon LLC. The image includes vial storage and usage details typical for prescription biologic drugs.*

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Figure B (Autoinjector)

An illustration showing a wrist with a watch displaying time and a pen-like device with a window and green element. The image likely demonstrates timing or use instructions for a device related to the Hadlima (adalimumab-bwwd) subcutaneous solution.*

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Figure C (Autoinjector)

Illustration showing components related to the Hadlima autoinjector, including the autoinjector device labeled "Hadlima Pushtronex" with a visible lot number area, an alcohol swab packet labeled "70% Isopropyl," a red sharps container marked "Sharps Container," and cotton balls or gauze pads. The image notes that the alcohol swab, sharps container, and cotton ball or gauze are not included in the carton.*

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Figure D (Autoinjector)

An instructional illustration showing a hand holding a Hadlima Prefilled Syringe. It highlights checking the syringe for particles and clarity, and verifying the expiration date on the label before use.*

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Figure E (Autoinjector)

An instructional illustration showing areas on the lower abdomen and thighs for subcutaneous injection. The image advises to clean the skin before injection, depicting an alcohol swab packet for preparation.*

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Figure F (Autoinjector)

An instructional illustration showing two hands removing a cap from a prefilled syringe, indicated by a blue arrow pointing to the left. The syringe is held horizontally in the right hand, and the left hand holds the cap being pulled off.*

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Figure G (Autoinjector)

Illustration showing a hand pressing down on a device with a downward arrow, labeled as Figure G with the instruction 'Click,' likely demonstrating how to activate or use a subcutaneous injection device.*

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Figure H (Autoinjector)

An instructional diagram showing a hand pressing down on a syringe or injection device, with a zoomed inset highlighting a yellow indicator line. The word "Click" is noted, indicating a step in the injection process, likely associated with administering Hadlima (adalimumab-bwwd) subcutaneously.*

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Figure I (Autoinjector)

An instructional illustration showing a hand holding a prefilled syringe with a yellow medicine window. The image includes text affirming the dose administration if the medicine window is yellow and no medicine leakage is visible. A red sharps container is depicted for disposal.*

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Samsung Logo (Image 35)

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Organon Logo (Image 36)

A product label indicating manufacturing information for Hadlima, displaying the name Organon LLC, a subsidiary of Organon & Co., with a location in Jersey City, NJ 07302, USA.*

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Figure A (Prefilled Syringe)

An instructional illustration labeled Figure A depicting components of a subcutaneous injection device. Visible parts labeled include needle cap, body with window, flange, and plunger.*

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Refrigerator (Image 38)

Hadlima 40 mg/0.4 mL subcutaneous injection solution label. The label includes active ingredient adalimumab-bwwd and is distributed by Organon LLC. It shows product name, strength, dosage form, and labeler information clearly in a typical vial label format.*

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Light (Image 39)

Hadlima 40 mg/0.8 mL solution for subcutaneous injection carton label. The packaging features the brand name Hadlima prominently, with the strength and dosage form clearly displayed. The label includes the manufacturer's name, Organon LLC. The design shows a patterned blue background and simple graphic elements, suggesting a pharmaceutical packaging for a human prescription drug.*

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Caution (Image 40)

Hadlima 40 mg/0.8 mL subcutaneous solution carton and vial packaging. The label displays the brand name Hadlima with the active ingredient adalimumab-bwwd. Product is marketed by Organon LLC. The packaging indicates a single-dose vial formulation.*

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Container (Image 41)

Hadlima 40 mg/0.4 mL solution for subcutaneous injection packaging carton, displaying the proprietary name, generic name adalimumab-bwwd, and labeler Organon LLC. The carton includes dosage and handling information along with product identification details.*

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Figure B (Prefilled Syringe)

An instructional illustration showing a hand with a wristwatch and a syringe or injection device next to it, likely indicating a timing or wait period during subcutaneous injection. The syringe is prepared for use, and the watch displays a time of approximately 3:30.*

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Figure C (Prefilled Syringe)

Figure C illustration showing a prefilled syringe for the subcutaneous solution Hadlima (adalimumab-bwwd), along with images of an alcohol swab, a sharps container, and cotton balls or gauze, noted as not included in the carton.*

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Figure D (Prefilled Syringe)

An instructional illustration depicting a hand holding a syringe. The image includes a checklist prompting verification that the solution is clear, contains no particles, and checking the expiration date. This type of figure is commonly used to guide proper medication inspection before administration.*

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Figure E (Prefilled Syringe)

Illustration showing a human figure with a focus on common subcutaneous injection sites including the abdomen and thighs, accompanied by an image of an alcohol swab package labeled 70% isopropyl. The figure includes a reminder to clean the skin prior to injection.*

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Figure F (Prefilled Syringe)

An instructional illustration showing two hands holding a syringe and a needle cap. The left hand is removing the needle cap from the syringe, indicated by a blue arrow pointing left, suggesting how to prepare the syringe for injection.*

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Figure G (Prefilled Syringe)

An instructional diagram showing a subcutaneous injection technique. The image depicts a hand holding a syringe at a 45-degree angle to the skin of the other hand, illustrating the proper angle for administering a subcutaneous injection.*

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Figure H (Prefilled Syringe)

Illustration showing the administration of Hadlima (adalimumab-bwwd) solution by subcutaneous injection. A hand is holding a syringe or autoinjector at the injection site on the forearm, indicating proper technique for self-injection.*

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Figure I (Prefilled Syringe)

An instructional illustration showing a hand holding a syringe near a sharps container. The text advises that the dose is complete if the needle is retracted and no medicine leaked out, noting that a small drop is acceptable.*

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Samsung Logo (Image 50)

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Organon Logo (Image 51)

The image shows a product label section indicating the manufacturer as Organon LLC, a subsidiary of Organon & Co., located in Jersey City, NJ, USA. This labeling is typical for pharmaceutical packaging or inserts.*

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Figure A (Autoinjector)

An illustration labeled Figure A depicting a subcutaneous injection device. The image highlights the needle cap, base, medicine window, and medicine label on the device, which corresponds to the delivery system for Hadlima (adalimumab-bwwd) solution.*

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Refrigerator (Image 53)

Hadlima 40 mg/0.8 mL solution for subcutaneous injection carton and box by Organon LLC. The packaging displays the product name, dosage form, strength, and labeler information with clear branding and regulatory labeling.*

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Light (Image 54)

Hadlima 40 mg/.4 mL subcutaneous solution box, a prescription human drug by Organon LLC. The packaging is predominantly white with blue and purple accent panels, displaying the product name and dosage strength on the front.*

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Caution (Image 55)

Hadlima 40 mg/0.8 mL solution for subcutaneous injection carton from Organon LLC. The label includes the proprietary name Hadlima and highlights the dosage strength of 40 mg/0.8 mL. The product is a human prescription drug in solution form, intended for subcutaneous administration.*

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Container (Image 56)

Hadlima 40 mg/0.4 mL subcutaneous solution single-dose vial packaging. The label includes the product name, strength, dosage form, and indications for use with the labeler indicated as Organon LLC.*

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Figure B (Autoinjector)

An instructional illustration labeled Figure B showing a wrist with a pink watch displaying a time and a subcutaneous injection device or pen positioned nearby, likely indicating timing or preparation for administration.*

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Figure C (Autoinjector)

An instructional illustration showing the Hadlima autoinjector pen along with an alcohol swab, a sharps container, and cotton balls or gauze, indicating items associated with subcutaneous injection but not included in the product carton.*

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Figure D (Autoinjector)

An instructional illustration showing a hand holding a Hadlima PushTouch syringe with a check to confirm the solution is clear and free of particles and a reminder to check the expiration date. The syringe is labeled with the brand name Hadlima.*

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Figure E (Autoinjector)

An instructional illustration showing potential subcutaneous injection sites on the human body, including the abdomen, upper arms, and thighs. The image includes a graphic of an alcohol swab packet labeled '70% Isopropyl.' Text instructs to clean the skin before injection.*

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Figure F (Autoinjector)

An illustration showing two hands holding a prefilled pen injector for subcutaneous use. One hand removes the protective cap from the pen by pulling it straight off. The pen pen likely relates to Hadlima (adalimumab-bwwd) injection, a human prescription drug for subcutaneous administration.*

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Figure G (Autoinjector)

An instructional illustration showing a hand holding an injection device vertically and pressing down to administer a subcutaneous injection, indicated by a downward arrow and the word 'Click.'*

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Figure H (Autoinjector)

An instructional diagram showing a hand holding a syringe in preparation for a subcutaneous injection in the forearm. The image includes a magnified inset highlighting the syringe's orange dose indicator, with the instruction to 'Click' for confirmation.*

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Figure I (Autoinjector)

An instructional illustration showing a hand holding a syringe with a medicine window that is yellow, indicating the dose was correctly received. The image includes a sharps container below, emphasizing safe disposal practices. It visually instructs on verifying the dose for a subcutaneous injection.*

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Samsung Logo (Image 65)

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Organon Logo (Image 66)

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Pdp (Single-dose Prefilled Syringe Carton 40 mg/0.8 mL)

Hadlima (adalimumab-bwwd) 40 mg/0.8 mL single-dose prefilled syringe carton. The label shows it is for subcutaneous injection, manufactured by Samsung Bioepis for Organon LLC. The packaging includes instructions to dispense the enclosed Medication Guide, storage instructions, and product contents details, with a bright pink background and clear dosage information on the front and side panels.*

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Pdp (Single-dose Autoinjector Carton 40 mg/0.8 mL)

Hadlima PushTouch (adalimumab-bwwd) injection 40 mg/0.8 mL single-dose prefilled autoinjector by Organon LLC and Samsung Bioepis. The label indicates subcutaneous use with 2 prefilled autoinjectors per carton. Instructions and storage information are provided, including refrigeration requirements and a warning not to remove the needle cap before injection.*

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Principal Display Panel (Single-dose Vial)

Packaging label for Hadlima (adalimumab-bwwd) injection, 40 mg/0.8 mL solution for subcutaneous use. The label indicates single-dose vial use, institutional use only, and disposal instructions. Labeler information includes Organon LLC and Samsung Bioepis. NDC 78206-185-01 is visible on the label.*

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Pdp (Single-dose Prefilled Syringe Carton 40 mg/0.4 mL)

Packaging label for Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL single-dose prefilled syringe by Organon LLC. The label includes storage instructions, contents of each syringe, and a visual of the syringe. The carton holds two single-dose syringes and additional instructions for use. The product is for subcutaneous use only.*

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Pdp (Single-dose Autoinjector Carton 40 mg/0.4 mL)

Packaging label for Hadlima PushTouch (adalimumab-bwwd) injection, 40 mg/0.4 mL single-dose prefilled autoinjector by Organon LLC. The carton contains 2 single-dose prefilled autoinjectors for subcutaneous use. The label includes storage instructions, a list of inactive ingredients, and a note that there is no button on the autoinjector. Manufactured by Samsung Bioepis.*

* 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.