Home NDC 65219-080-01 NDC 65219-080-01 - Gadoterate Meglumine This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 65219-080
Requested NDC 65219-080-01
Package NDCs from labels 65219-080-01, 65219-080-05
Manufacturer Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
Effective date 2025-11-06
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Labels# Label, Manufacturer, Effective date table Label Manufacturer Effective date Type Gadoterate Meglumine Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) 2025-11-06 HUMAN PRESCRIPTION DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-080-01 Gadoterate Meglumine 5 mL in 1 VIAL INJECTION 5 4 65219-080-01 Gadoterate Meglumine 1 in 1 CARTON INJECTION 1 4 65219-080-05 Gadoterate Meglumine 10 in 1 BOX INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-080 GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 3 package rows 20240217_e0655aac-9508-4141-94f5-fcca6af1c41d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 3 of 9 · 170 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kollourion Eyesalve Eyewash PURIFIED WATER 98.3% Miracle Eye Pharmaceuticals b56d2ab9-169b-b490-e053-2a95a90a80b3 2025-12-28 Warnings Exact identifier unii: 059QF0KO0R Sterile Water WATER ProPharma Distribution 386a0a2f-4ff7-f128-e063-6294a90a7d4d 2025-12-18 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Firstep Firstflush EYEWASH Encon Safety Products, Inc. a44beb26-79ae-98bd-e053-2995a90a9b74 2025-12-09 Warnings Exact identifier unii: 059QF0KO0R PUR-WASH WATER Niagara Pharmaceuticals Inc. beda35c3-9a8b-47ad-e053-2995a90a7b1b 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R Easy Care First Aid Eyewash WATER Tender Corporation a070aac8-e6d2-ef10-e053-2a95a90aa5b1 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R PUR-WASH WATER Niagara Pharmaceuticals Inc. e07a064b-f680-405c-bbcd-24fac430951e 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R ULINE Eyewash EYEWASH Niagara Pharmaceuticals Inc. 2d7f22d2-320b-6af1-e063-6294a90addc6 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R Pur-Wash EYEWASH Niagara Pharmaceuticals, Inc. 0d43b1c1-2699-37f1-e054-00144ff88e88 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R PUR-WASH WATER Niagara Pharmaceuticals Inc. 777e1559-786f-8d54-e053-2991aa0aa98d 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R PUR-WASH WATER Niagara Pharmaceuticals Inc. 7289103a-5cbf-42f4-8848-e827149a43ca 2025-11-24 Warnings Exact identifier unii: 059QF0KO0R Eyewash Additive Concentrate WATER AND PROPYLENE GLYCOL Haws Corporation dd168403-398c-41ff-b1df-d93e4ff39de3 2025-11-20 Warnings Exact identifier unii: 059QF0KO0R Sterile Water WATER Fresenius Kabi USA, LLC fd823bef-c14c-4708-a18a-8aaa8470412f 2025-11-18 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Eyesaline Eyewash Concentrate PURIFIED WATER Honeywell Safety Products USA, Inc. 3765c251-eb14-d60f-e063-6294a90a6a4d 2025-11-12 Warnings Exact identifier unii: 059QF0KO0R Eyesaline Emergency Eyewash PURIFIED WATER Honeywell Safety Products USA, Inc. 37f244fd-c02f-e66a-e063-6394a90aed81 2025-11-12 Warnings Exact identifier unii: 059QF0KO0R STERILE WATER WATER Henry Schein, Inc. f4087143-9868-4308-b96c-43657ee8ec28 2025-11-07 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Gadoterate Meglumine GADOTERATE MEGLUMINE Fresenius Kabi USA, LLC fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709 2025-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier unii: L0ND3981AG Gadoterate Meglumine GADOTERATE MEGLUMINE Fresenius Kabi USA, LLC e0655aac-9508-4141-94f5-fcca6af1c41d 2025-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: ANDA215304 ndc (package): 65219-084-15 ndc (package): 65219-086-20 ndc (package): 65219-080-05 ndc (package): 65219-082-01 ndc (package): 65219-082-10 ndc (package): 65219-084-01 ndc (package): 65219-080-01 ndc (package): 65219-086-01 ndc (product): 65219-082 ndc (product): 65219-080 ndc (product): 65219-084 ndc (product): 65219-086 ndc11 (package): 65219008001 spl id: f05922b7-99d4-48c7-972a-7966bbbbc3b4 spl set id: e0655aac-9508-4141-94f5-fcca6af1c41d unii: L0ND3981AG Bacteriostatic Water BACTERIOSTATIC WATER ProPharma Distribution 42c6938e-f747-ae13-e063-6294a90a59a3 2025-11-04 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Sterile Water WATER ICU Medical Inc. aab10f03-26ae-4dbc-a481-ef025e48b405 2025-11-02 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Sterile Water WATER ICU Medical Inc. e3484bc6-ed7f-43ef-9d49-c131a8dff2dd 2025-11-02 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.