Structural Formula (Gad00 0001 01)
Gadoterate Meglumine Injection
Product Images NDC 65219-084
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gadoterate Meglumine (NDC 65219-084). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Fresenius Kabi 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.
Product Images & Figures Index
Fresenius Kabi Logo (Gad00 0001 02)
Principal Display Panel – 2.5 Mmol Per 5 mL Tray Label (Gad00 0001 03)
This is a description for Gadoterate Meglumine Injection. It is a sterile solution used for intravenous administration. The solution is stored at 25°C (77°F) with excursions allowed between 15° to 30°C. Each mL contains 376.9 mg of gadoterate meglumine with a strength of (0.5 mmol per mL). The solution comes in 10 single-dose vials of 5 mL each, and the unused solution should be discarded. The product is manufactured for Fresenius Kabi in Lake Zurich, IL, and has a GTIN of 20365219080057. There is a barcode line and the lot/expiry is mentioned. The label indicates that the product is made in China.*
Principal Display Panel – 2.5 Mmol Per 5 mL Carton (Gad00 0001 04)
This is a description of Gadoterate Meglumine Injection, USP, a sterile solution used for intravenous administration. It comes in a 5 mL single-dose vial with a concentration of 0.5 mmol per mL. The solution contains gadoterate meglumine, DOTA, and water for injection. The usual dosage is indicated in the package insert. Each patient must receive the accompanying medication guide. Unused portion should be discarded. It is manufactured for Fresenius Kabi in Lake Zurich, IL, and made in China. Store at the recommended temperature range.*
Principal Display Panel – 2.5 Mmol Per 5 mL Vial Label (Gad00 0001 05)
This appears to be a label for a medication called Gadoterate Meglumine Injection, used for intravenous administration. The suggested storage temperature is provided, along with information about the concentration of the solution. The label also includes relevant codes, numbers and warnings.*
Principal Display Panel – 5 Mmol Per 10 mL Tray Label (Gad00 0001 06)
This text describes a medicine called Gadoterate Meglumine Injection USP with a composition of 376.9 mg of gadoterate meglumine and 0.25 mg of DOTA, both per mL of water for injection. The recommended dosage is provided within the package. It comes in 10 mL single-dose vials and should be stored within the room temperature limits of 15°C to 30°C. The sterile solution should not be used if the packaging is unused or if it is expired. The manufacturer is Fresenius Kabi, and the barcode will be printed online. The lot number and one-dimensional code can be seen. There is also a reference to the product being made in China.*
Principal Display Panel – 5 Mmol Per 10 mL Carton (Gad00 0001 07)
This is a description of Gadoterate Meglumine, an injection solution manufactured by Fresenius. The solution is dispensed in a 10 mL single-dose vial and is intended for intravenous administration only. Each mL contains 376.9 mg of gadoterate meglumine and 0.25 mg of DOTA. It is meant to be used with water for injection and comes with a medication guide to give each patient. The usual dosage should be referred to using the package insert. The solution should be stored at a controlled room temperature within the range of 15°C to 30°C.*
Principal Display Panel – 5 Mmol Per 10 mL Vial Label (Gad00 0001 08)
This is a product label for a sterile solution called Gadoterate Meglumine Injection. It is stored at 25°C with permissible excursions up to 25°C. The injection comes in a single dose vial containing 10 ml with 5 mmol of Gadoterate Meglumine per 10 ml. The manufacturer is Fresenius and the product is made in China. The product is a prescription drug and unused portions should be discarded.*
Principal Display Panel – 7.5 Mmol Per 15 mL Tray Label (Gad00 0001 09)
This is a description of Gadoterate Meglumine injection, which is a sterile solution available in 10 x 15 mL single dose vials. Each mL contains 376.9 mg of gadoterate meglumine and 0.25 mg of DOTA with water for injection. The package insert should be consulted for the recommended dosage. The solution should be stored at room temperature and discarded if unused. The product is for intravenous administration and the manufacturer is RhFresenius Kabi. Lot/expiration information is indicated on the packaging, which includes a barcode. The product is made in China.*
Principal Display Panel – 7.5 Mmol Per 15 mL Carton (Gad00 0001 10)
This is a description of a pharmaceutical product with NDC number 65219-084-01. The product is called Gadoterate Meglumine, which is an injection that contains 7.5 mmol per 1 (0.5 mmol per mL) of the active ingredient. It is meant for intravenous administration and packaged in a 15 mL single dose vial. The medication guide is recommended for each patient who is using the product. The usual dosage should be as per the package instruction. The unused portion of the product should be discarded, and the product should be stored at controlled room temperature (25°C or 77°F) with excursions of 15° to 30°C (59°to 86°F) permitted as directed by USP standards. The product is manufactured by Fresenius Kabi in China.*
Principal Display Panel – 7.5 Mmol Per 15 mL Vial Label (Gad00 0001 11)
This is a description of a medication called "Gadoterate Meglumine Injection, USP", which is a sterile solution that is administered intravenously. Each 15ml single-dose vial contains 5mmol per 15 (0.5 mmol per mL) of the drug. Unused portion of the vial should be discarded. It is recommended for Rx only and should be stored at a controlled room temperature between 15°C and 30°C. The manufacturer of this medication is Fresenius Knt Els.*
Principal Display Panel – 10 Mmol Per 20 mL Tray Label (Gad00 0001 12)
This is a description of a medication with NDC number 65219-086-20 which contains gadoterate meglumine, DOTA, and water for injection. The dosage should be as per the package insert. It comes in a pack of 10 vials, each containing 20 mL of the solution to be used for intravenous administration only. It should be stored at 25°C (77°F), with excursions to 15° to 30°C. Any unused portion should be discarded. The manufacturer is Rh Fresenius Kabi and it is made in China. There is also information about the barcode, lot/exp, and manufacturer's website.*
Principal Display Panel – 10 Mmol Per 20 mL Carton (Gad00 0001 13)
Gadoterate Meglumine Injection is a sterile solution that contains 0.5 mmol per mL of gadoterate meglumine, 025 mg of DOTA, and water for intravenous administration. It comes in a 20 mL single-dose vial that is discarded when unused. The usual dosage for the injection is given in the package insert. Each patient must be given the accompanying medication guide. The product is manufactured by FRESENIUS KABI in Lake Zurich, IL 60047, and made in China. The solution must be stored at a temperature of 25°C (77°F), and excursions are allowed from 15°C to 30°C (5 to 86°F) as per USP Controlled Room Temperature guidelines.*
Principal Display Panel – 10 Mmol Per 20 mL Vial Label (Gad00 0001 14)
* 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.
