Regulations research / FDA data / Drug shortages / Gadoterate Meglumine Injection Drug shortages Gadoterate Meglumine Injection Jiangsu Hengrui Pharmaceuticals Co., Ltd.
2026-06-30 To Be Discontinued 65219-084-15 Medical Imaging
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Discontinued date 06/30/2026
Update type New
Initial posting date 06/30/2026
Package NDC 65219-084-15
Generic name Gadoterate Meglumine Injection
Contact info 888-386-1800
Related info Marketed by Fresenius Kabi, USA; Discontinuation of the manufacture of the drug
Update date 06/30/2026
Dosage form Injection
Presentation Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15)
Company name Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Status To Be Discontinued
Therapeutic category Medical Imaging Harmonized identifiers (openFDA)
Application number ANDA215304
Brand name GADOTERATE MEGLUMINE
Generic name GADOTERATE MEGLUMINE
Manufacturer name Fresenius Kabi USA, LLC
Product NDC 65219-084, 65219-080, 65219-082, 65219-086
Product type HUMAN PRESCRIPTION DRUG
Route INTRAVENOUS
Substance name GADOTERATE MEGLUMINE
SPL ID f05922b7-99d4-48c7-972a-7966bbbbc3b4
SPL set ID e0655aac-9508-4141-94f5-fcca6af1c41d
Package NDC 65219-080-01, 65219-080-05, 65219-082-01, 65219-082-10, 65219-084-01, 65219-084-15, 65219-086-01, 65219-086-20
UNII L0ND3981AG Drug shortages Gadoterate Meglumine Injection Jiangsu Hengrui Pharmaceuticals Co., Ltd.
2026-05-21 To Be Discontinued 65219-084-15 Medical Imaging
Open FDA's page for this record
Discontinued date 05/21/2026
Update type New
Initial posting date 05/21/2026
Package NDC 65219-084-15
Generic name Gadoterate Meglumine Injection
Contact info Marketed by Fresenius Kabi, USA; Customer service: 888-386-1300
Related info Discontinuation of the manufacture of the drug
Update date 05/21/2026
Dosage form Injection
Presentation Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15)
Company name Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Status To Be Discontinued
Therapeutic category Medical Imaging Harmonized identifiers (openFDA)
Application number ANDA215304
Brand name GADOTERATE MEGLUMINE
Generic name GADOTERATE MEGLUMINE
Manufacturer name Fresenius Kabi USA, LLC
Product NDC 65219-084, 65219-080, 65219-082, 65219-086
Product type HUMAN PRESCRIPTION DRUG
Route INTRAVENOUS
Substance name GADOTERATE MEGLUMINE
SPL ID f05922b7-99d4-48c7-972a-7966bbbbc3b4
SPL set ID e0655aac-9508-4141-94f5-fcca6af1c41d
Package NDC 65219-080-01, 65219-080-05, 65219-082-01, 65219-082-10, 65219-084-01, 65219-084-15, 65219-086-01, 65219-086-20
UNII L0ND3981AG Wholesale access for licensed clinicians. Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.
Data from openFDA , FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.
