Hemgenix Kit
Product Images NDC 0053-0200

Product Visual Gallery

This gallery contains 42 technical images submitted to the FDA as part of the official labeling for Hemgenix (NDC 0053-0200). 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)

This is a description of a medical product called "etranacogene dezaparvovec-drlb" which is a suspension for intravenous infusion. It is contained in a single-dose vial and its concentration is 1x10 genome copies/mL. The text provides a cautionary instruction not to shake and to dilute before use. The name of the manufacturer is Hemgenix, and the product has been licensed in the United States.*

FDA Label Image

Principal Display Panel (10 ml Vial Carton)

This is a drug description about a product called 'etranacogene dezaparvovecrlb HEMGENIX' made by uniQure and manufactured for CSLBehring. The product is a suspension for intravenous infusion and comes in a single-dose vial containing 1x107 genome copies/mL. The drug should be stored refrigerated at a temperature of 2°C to 8°C (36°F to 46°F), and it should be protected from light and not frozen. It is advised to discard any unused portion. The description includes some dosage and usage instructions, but these are not provided in the text.*

FDA Label Image

Principal Display Panel (Kit Carton)

Etranacogene dezaparvovec-drlb is a suspension for intravenous infusion contained in a single-dose vial with a concentration of 1x 10" genome copies/mL. It should be kept refrigerated at 2°C to 8°C (36°F to 46°F) upon receipt and not frozen. The manufactured drug should be protected from light and not shaken before use. For dosage and directions, review the enclosed prescribing information. The drug contains no preservatives, and any unused portions should be discarded.*

FDA Label Image

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

This appears to be a medication packaging description. The package contains a vial of 10 ml volume and corresponds to the National Drug Code (NDC) 0053-0100-10.*

FDA Label Image

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

This is a product identification code for a medication presented in a 10mL vial. The NDC code is NDC0053-0110-11. No information is available regarding the medication's name or purpose.*

FDA Label Image

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

This is a drug label of a 10 mL vial with NDC number 0053-0120-12. There is no information about the drug name or its indication.*

FDA Label Image

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

This appears to be a medication label with the NDC code of "0053-0130-13". It comes in a 10 milliliter vial and there are approximately 13 vials in the package. No information about the medication name, manufacturer or purpose has been provided.*

FDA Label Image

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

The text describes a pharmaceutical product with the National Drug Code (NDC) 0053-0140-14. It comes in a vial of 10ml, and there are approximately 14 vials in the packaging.*

FDA Label Image

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

This appears to be the label information for a medication with the National Drug Code (NDC) number 0053-0150-15. The medication is provided in 10mL vials and this label corresponds to one vial of the medication.*

FDA Label Image

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

This is a medication package of a 10mL vial containing 16 individual doses. The package identifier (NDC) code is 0053-0160-16.*

FDA Label Image

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

This appears to be a pharmaceutical product label. The NDC (National Drug Code) is specified as 0053-0170-17, which is a unique identifier assigned to drugs intended for human use in the United States. The other barcode appears to be a GTIN (Global Trade Item Number), which is a unique identifier assigned to products that have been manufactured or traded. The product is likely contained in a 10ml vial. No further information can be obtained.*

FDA Label Image

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

This appears to be a product code for a medication, specifically a 10 mL vial containing a quantity of 18. The National Drug Code (NDC) for this product is 0053-0180-18. However, it does not provide any information regarding the name or purpose of the medication.*

FDA Label Image

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

This appears to be medication packaging information. The National Drug Code (NDC) is 0053-0190-19 and the medication appears to come in a 10mL vial with approximately 19 doses.*

FDA Label Image

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

This is a medication label. The NDC code is 0053-0200-20, and the GTIN is not written. The medication is available in a 10ml vial and there are 20 vials in the package.*

FDA Label Image

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

This is a product description of a medication with NDC code 00530210-21. The medication comes in a vial size of 10 mL and there are 21 vials included in the package. No information about the medication's name, purpose or manufacturer is given.*

FDA Label Image

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

The text contains a NDC code for a 10 mL vial. No further information is available.*

FDA Label Image

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

This is a product code for a 10mL vial with the NDC number 00530230-23. No further information is available.*

FDA Label Image

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

This text appears to be a product code and label information for a pharmaceutical product. It includes a National Drug Code (NDC) number of "00530240-24" and a volume size of "10mL". Without additional context, it is unclear what specific medication this label is attached to.*

FDA Label Image

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

This text appears to be a medical code or identification number, specifically a National Drug Code (NDC), with the code "0053-0250-25" referring to a 10 mL vial. The first line of text may be another identification number that follows a different format.*

FDA Label Image

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

This appears to be a product label or packaging information for a medication. The item is contained in a vial or container that holds 10 mL of the medication. The product is designated by the National Drug Code (NDC) of 0053-0260-26. No further information about the medication or its uses is available from this text.*

FDA Label Image

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

This is a medical product with NDC code 0053-0270-27 available in 10 mL vials. The rest of the text seems to be product identification numbers and not a useful description.*

FDA Label Image

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

This appears to be a code for a medication in the United States with the National Drug Code (NDC) of 0053-0280-28. The code may refer to a 10 mL vial, however, it is not clear what medication it is for or what its uses are.*

FDA Label Image

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

This appears to be a medication label or packaging information. It includes the National Drug Code (NDC) number 0053-0290-29, which helps identify the medication, and indicates it is in a vial size of 10 mL, with approximately 29 vials.*

FDA Label Image

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

This appears to be a medication or drug information label. The National Drug Code (NDC) is 0053-0300-30, and the medication is available in vials of 10 mL each, with 30 vials in a package or box. Further information about the medication is not available from the text provided.*

FDA Label Image

Principal Display Panel (151-155 kg Variable Label)

This appears to be a medication packaging label. The National Drug Code (NDC) is 0053-0310-31, and the medication is in a 10 mL vial. The rest of the text is not quite clear and cannot be determined.*

FDA Label Image

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

This is a product identification code containing a National Drug Code (NDC) and a Global Trade Item Number (GTIN). The NDC identifies this specific drug product and can be used to access information about the drug's manufacturer, ingredients, and usage. The GTIN is a globally unique identification number used to identify trade items. The remaining text is unclear and not informative.*

FDA Label Image

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

This text seems to be a product code for a medication. The medication's National Drug Code (NDC) is 0053-0330-33, and it comes in a 10mL vial. The rest of the text appears to be internal coding and is not relevant to the end-user.*

FDA Label Image

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

This text appears to be a product code for a medication in the United States. It includes the NDC (National Drug Code) number, which is a unique identifier for drugs approved by the FDA. The code may be used by healthcare providers, insurance companies, and pharmacies to track and verify medication orders and claims. The specific medication or product name, dosage, and manufacturer information are not available from this text.*

FDA Label Image

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

This is a medication labeling information related to a 10 mL vial of a drug with National Drug Code (NDC) 0053-0350-35. The rest of the text might indicate a product code or batch number, but it's not entirely clear.*

FDA Label Image

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

This appears to be the information about a medication in the format typically used by the National Drug Code (NDC) system in the United States. The medication is likely contained in a vial of 10 milliliters, and the code can be used to identify the medication, manufacturer, and packaging size.*

FDA Label Image

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

This appears to be information on a pharmaceutical product with a National Drug Code (NDC) of 0053-0370-37, possibly in a 10 mL vial. The first line may be a different code or identifier. There is no further information to provide a more detailed description.*

FDA Label Image

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

This appears to be a product or medication identifier. It includes a code, "NDC0053-0380-38", which may be a National Drug Code (NDC) assigned by the U.S. Food and Drug Administration. The code is associated with a 10 ml vial, but the purpose or contents of the product are not specified.*

FDA Label Image

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

This appears to be a product code for a medication in the form of a 10 milliliter vial. The code includes an NDC (National Drug Code) number of 0053-0390-39. The purpose or name of the medication is not provided in this information.*

FDA Label Image

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

This appears to be a description of a pharmaceutical product that comes in a vial of 10 milliliters and a quantity of approximately 40 units. The product's identification number is NDC0053-0400-40.*

FDA Label Image

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

The text contains NDC and product code information for a 10mL vial. It is not clear what the product is or what the numbers represent beyond the identification codes.*

FDA Label Image

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

This text seems to be a drug code and packaging information, indicating that the drug comes in a 10mL vial and the package contains 42 vials. However, it is not possible to determine the name or type of drug from this information alone.*

FDA Label Image

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

This appears to be a product code for a pharmaceutical item but it's difficult to determine the specific product without additional context. The code includes a National Drug Code (NDC) and a vial size.*

FDA Label Image

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

This appears to be a product code for a 10mL vial, possibly for a medication, with the NDC code 0053-0440-44. However, without additional context, it is difficult to determine the specific product or medication.*

FDA Label Image

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

This appears to be information from a medicine label. It includes the National Drug Code (NDC) number of the medicine, which is 0053-0450-45, and the size of the vial, which is 10mL. The rest of the text is not providing any useful information.*

FDA Label Image

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

This is a pharmaceutical product with a National Drug Code (NDC) of NDC0053-0460-46. The GTIN (Global Trade Item Number) is not available. The package consists of a 10mL vial and there is a product identification code of 01)00300530460467.*

FDA Label Image

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

The text seems to be a combination of a National Drug Code (NDC) and some product information. The product seems to come in a 10 milliliter vial and there are 47 of them. The NDC is 00530470-47.*

FDA Label Image

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

This appears to be a medication product code for a 10 mL vial with a quantity of approximately 48 units. No specific medication name or active ingredients are provided.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.