Hemgenix Kit
Product Images NDC 0053-0210

Product Visual Gallery

This gallery contains 42 technical images submitted to the FDA as part of the official labeling for Hemgenix (NDC 0053-0210). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Csl Behring, 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

Principal Display Panel (10 ml Vial Label)

HEMGENIX (etranacogene dezaparvovec-kit) label showing a 10 ml suspension for intravenous infusion. The label indicates a concentration of 1x10¹³ genome copies per ml, single-dose vial, with instructions not to shake and to dilute before use. Manufactured by uniQure, Inc. and marked distributed by CSL Behring LLC.*

FDA Label Image

Principal Display Panel (10 ml Vial Carton)

HEMGENIX kit containing etranacogene dezaparvovec-drlb suspension for intravenous infusion, labeled with a concentration of 1 x 10^13 genome copies/mL. The kit includes a single-dose vial, storage instructions to refrigerate at 2°C to 8°C (36°F to 46°F), warnings against freezing and shaking, and notes on dilution before use. Manufactured for CSL Behring with additional manufacturing details by uniQure, Inc. The packaging displays dosage, handling instructions, and regulatory information.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for HEMGENIX (etranacogene dezaparvovec-drlb) 1 x 10¹³ genome copies/mL suspension for intravenous infusion. It is a single-dose vial, 10 mL vial size. The label includes storage instructions to refrigerate at 2°C to 8°C, warnings such as Do Not Freeze, Do Not Shake, and instructions to dilute before use. Manufactured by uniQure, Inc. and labeled/ distributed by CSL Behring LLC. Barcode and lot information area also present on the label.*

FDA Label Image

Principal Display Panel (NDC: 0053-0100-10_ 46-50 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit containing ten 10 mL vials. The label has a pink background and includes a barcode with the NDC 0053-0100-10. It also has a blue QR code area with fields for GTIN, SN, EXP, and LOT information. Labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0110-11_ 51-55 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit containing eleven 10 mL vials. The label includes a barcode with an NDC number 0053-0110-11 and space for GTIN, serial number, expiration date, and lot number. The label background is pink, and the product is labeled by CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0120-12_ 56-60 KG KIT VARIABLE LABEL)

Label for HEMGENIX kit by CSL Behring showing product packaging information. It indicates a 10 mL vial in a pack of 12. The label includes a barcode with NDC 0053-0120-12 and fields for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0130-13_ 61-65 KG KIT VARIABLE LABEL)

Label panel for HEMGENIX kit containing 10 mL vials, with a pink background. It displays a barcode with NDC 0053-0130-13 and fields for GTIN, serial number (SN), expiration date (EXP), and lot number (LOT). Labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0140-14_ 66-70 KG KIT VARIABLE LABEL)

Packaging label of HEMGENIX kit, a human prescription drug containing etranacogene dezaparvovec, from CSL Behring. The label background is pink with a barcode and an NDC number 0053-0140-14, indicating the product packaging of 10 mL vials, quantity 14. Additional data fields for GTIN, serial number, expiration date, and lot number are visible but not filled in.*

FDA Label Image

Principal Display Panel (NDC: 0053-0150-15_ 71-75 KG KIT VARIABLE LABEL)

Label from HEMGENIX kit by CSL Behring showing a pink background with a barcode and NDC 0053-0150-15. The label indicates a 10 mL vial and a quantity of 15. Identifiers including GTIN, SN, EXP, and LOT are printed but not filled in.*

FDA Label Image

Principal Display Panel (NDC: 0053-0160-16_ 76-80 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX etranacogene dezaparvovec kit by CSL Behring, showing a barcode and NDC number 0053-0160-16. The label indicates a 10 mL vial with placeholder fields for GTIN, serial number, expiration date, and lot number on a pink background.*

FDA Label Image

Principal Display Panel (NDC: 0053-0170-17_ 81-85 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring. The label shows a pink background with barcode, QR code, and text indicating 10 mL vial x 17. The label includes space for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0180-18_ 86-90 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring. The label features a pink background, a barcode with NDC 0053-0180-18, and space for GTIN, serial number, expiration date, and lot number. The package indicates '10 mL vial x 18.'*

FDA Label Image

Principal Display Panel (NDC: 0053-0190-19_ 91-95 KG KIT VARIABLE LABEL)

Label for HEMGENIX (etranacogene dezaparvovec) kit, showing a pink background with a barcode and NDC 0053-0190-19. The label indicates a package containing a 10 mL vial, including fields for GTIN, serial number, expiration date, and lot number. The labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0200-20_ 96-100 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit containing 20 vials of 10 mL each. The label features a barcode with the NDC 0053-0200-20 and a QR code alongside placeholders for GTIN, serial number, expiration date, and lot number. The product is labeled by CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0210-21_ 101-105 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit. The label has a pink background with a barcode and the NDC number 0053-0210-21. It indicates that the package contains 21 vials of 10 mL each. The label is from CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0220-22_ 106-110 KG KIT VARIABLE LABEL)

Label for HEMGENIX (etranacogene dezaparvovec) kit, manufactured by CSL Behring. The label includes a barcode with NDC 0053-0220-22 and indicates a package size of 22 units of 10 mL vials. Additional label areas for GTIN, serial number, expiration date, and lot number are shown but not filled in.*

FDA Label Image

Principal Display Panel (NDC: 0053-0230-23_ 111-115 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) KIT by CSL Behring. The label is pink with a barcode and a QR code. It indicates a package containing 23 units of 10 mL vials. The NDC number 0053-0230-23 is also shown.*

FDA Label Image

Principal Display Panel (NDC: 0053-0240-24_ 116-120 KG KIT VARIABLE LABEL)

Label for HEMGENIX kit containing 24 vials of 10 mL each. The label is pink with a barcode and NDC number 0053-0240-24. Data matrix code is present along with placeholders for GTIN, serial number, expiration date, and lot number. Labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0250-25_ 121-125 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring, showing a 10 mL vial with the quantity of 25. The label includes a barcode with the NDC 0053-0250-25 and fields for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0260-26_ 126-130 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring. The label is predominantly pink and includes a barcode with the NDC number 0053-0260-26. It mentions a 10 mL vial quantity of 26. Additional identifiers like GTIN, SN, EXP, and LOT are indicated without specific values.*

FDA Label Image

Principal Display Panel (NDC: 0053-0270-27_ 131-135 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX etranacogene dezaparvovec kit. The label features a pink background with a barcode and the NDC number 0053-0270-27. It specifies a 10 mL vial with a quantity of 27. Additional information fields for GTIN, serial number, expiration date, and lot number are indicated but not filled in. The labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0280-28_ 136-140 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit from CSL Behring. The label features a pink background with a barcode and NDC number 0053-0280-28. It indicates a package containing 28 units of 10 mL vials. Additional identification fields such as GTIN, serial number, expiration, and lot are present but not filled.*

FDA Label Image

Principal Display Panel (NDC: 0053-0290-29_ 140-145 KG KIT VARIABLE LABEL)

Label for HEMGENIX (etranacogene dezaparvovec) kit with NDC 0053-0290-29, manufactured by CSL Behring. The label is pink with barcode and 2D matrix code. It indicates a 10 mL vial package size and includes placeholders for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0300-30_ 146-150 KG KIT VARIABLE LABEL)

Label panel for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring. The label features a pink background with a barcode and NDC 0053-0300-30. It indicates a packaging size of 10 mL vial x 30. Additional data fields for GTIN, SN, EXP, and LOT are present but without visible values.*

FDA Label Image

Principal Display Panel (151-155 kg Variable Label)

Label panel for HEMGENIX (etranacogene dezaparvovec) kit, showing a pink background with a barcode and NDC 0053-0310-31. The label indicates a 10 mL vial x 31 count. It includes a QR code and placeholders for GTIN, serial number (SN), expiration (EXP), and lot number (LOT). Labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0320-32_ 156-160 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring showing a barcode with NDC 0053-0320-32 and a designation for a 10 mL vial x 32 count. The label includes placeholders for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0330-33_ 161-165 KG KIT VARIABLE LABEL)

Package label for HEMGENIX etranacogene dezaparvovec KIT by CSL Behring. The label includes a barcode, NDC number 0053-0330-33, and indicates a quantity of thirty-three 10 mL vials. Additional spaces for GTIN, serial number, expiration date, and lot number are present but not filled in.*

FDA Label Image

Principal Display Panel (NDC: 0053-0340-34_ 166-170 KG KIT VARIABLE LABEL)

Packaging label of HEMGENIX etranacogene dezaparvovec kit by CSL Behring, showing barcode with NDC 0053-0340-34. The label mentions a 10 mL vial and includes data fields for GTIN, serial number, expiration date, and lot number, printed on a pink background.*

FDA Label Image

Principal Display Panel (NDC: 0053-0350-35_ 171-175 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring, showing a pink background with a barcode, a 2D matrix code, and listing a package size of 10 mL vial x 35. The label includes placeholders for GTIN, serial number, expiration date, and lot number, along with NDC 0053-0350-35.*

FDA Label Image

Principal Display Panel (NDC: 0053-0360-36_ 176-180 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit by CSL Behring featuring a pink background. The label includes a barcode with NDC 0053-0360-36, fields for GTIN, serial number (SN), expiration date (EXP), and lot number (LOT), a QR code, and indicates contents of 10 mL vial x 36.*

FDA Label Image

Principal Display Panel (NDC: 0053-0370-37_ 181-185 KG KIT VARIABLE LABEL)

Packaging label of HEMGENIX, a kit dosage form of etranacogene dezaparvovec by CSL Behring. The label is pink and includes a barcode with NDC 0053-0370-37, a QR code, and text referencing vial size and lot information.*

FDA Label Image

Principal Display Panel (NDC: 0053-0380-38_ 186-190 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit containing etranacogene dezaparvovec. The label is pink with a barcode and NDC number 0053-0380-38. It indicates a 10 mL vial quantity of 38 units. The labeler is CSL Behring. GTIN, serial number, expiration, and lot placeholders are present but unpopulated.*

FDA Label Image

Principal Display Panel (NDC: 0053-0390-39_ 191-195 KG KIT VARIABLE LABEL)

Label of HEMGENIX kit containing 10 mL vials, package of 39. The label shows the product’s NDC 0053-0390-39 with barcode and includes sections for GTIN, serial number, expiration date, and lot number. The label’s background color is pink, and the labeler is CSL Behring.*

FDA Label Image

Principal Display Panel (NDC: 0053-0400-40_ 196-200 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring. The label shows a pink background with a barcode and NDC number 0053-0400-40. It also indicates packaging for 40 units of 10 mL vials, with spaces for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0410-41_ 201-205 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit by CSL Behring. The label features a pink background with a barcode and NDC number 0053-0410-41. It indicates the kit contains a 10 mL vial with lot, expiration, serial number, and GTIN information areas near a blue QR code.*

FDA Label Image

Principal Display Panel (NDC: 0053-0420-42_ 206-210 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit, manufactured by CSL Behring. The label includes a barcode with NDC 0053-0420-42, a QR code with identifiers for GTIN, serial number, expiration date, and lot number, and indicates the package contains a 10 mL vial with a quantity of 42.*

FDA Label Image

Principal Display Panel (NDC: 0053-0430-43_ 211-215 KG KIT VARIABLE LABEL)

Packaging label of HEMGENIX kit by CSL Behring featuring a pink background, barcode with NDC 0053-0430-43, 10 mL vial size, and space for GTIN, serial number, expiration date, and lot number.*

FDA Label Image

Principal Display Panel (NDC: 0053-0440-44_ 216-220 KG KIT VARIABLE LABEL)

Label panel for HEMGENIX kit by CSL Behring showing a pink background with a barcode and NDC 0053-0440-44. The label also displays placeholders for GTIN, serial number, expiration date, and lot number along with text indicating '10 mL vial x 44.'*

FDA Label Image

Principal Display Panel (NDC: 0053-0450-45_ 221-225 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit by CSL Behring, showing a pink background with a barcode and human prescription drug identifier. The label includes a 10 mL vial x 45 count indicator, GTIN, serial number, expiration date, and lot number fields, each with corresponding placeholders.*

FDA Label Image

Principal Display Panel (NDC: 0053-0460-46_ 226-230 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX kit by CSL Behring showing a pink background with a barcode, GTIN, serial number, expiration, and lot number placeholders. The label indicates a 10 mL vial with an NDC number 0053-0460-46 and the quantity '46' printed in blue.*

FDA Label Image

Principal Display Panel (NDC: 0053-0470-47_ 231-235 KG KIT VARIABLE LABEL)

Label for HEMGENIX etranacogene dezaparvovec kit by CSL Behring. The label is pink with a barcode and NDC 0053-0470-47, indicating a 10 mL vial kit. The label includes spaces for GTIN, serial number, expiration date, and lot number details.*

FDA Label Image

Principal Display Panel (NDC: 0053-0480-48_ 236-240 KG KIT VARIABLE LABEL)

Packaging label for HEMGENIX (etranacogene dezaparvovec) kit from CSL Behring. The label is pink and includes a barcode with NDC 0053-0480-48 and indicates the packaging contains 10 mL vials, quantity 48. Additional details include a QR code area with GTIN, serial number, expiration date, and lot number fields.*

* 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.