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 | 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 | 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#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-080-01 | ML - Milliliter | 65219-080 | 8572314e-493a-465c-93f1-d8dd69d1908b | 1 | 2022-10-06 |
| 65219-080-05 | ML - Milliliter | 65219-080 | 33b825cb-8187-4d8c-80bc-5d876c627904 | 1 | 2022-10-06 |
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.
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|---|---|---|---|---|---|---|
| Anubis Barcelona Regul OIl | PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT | ANUBIS COSMETICS SL | eb905bd0-c600-b8b2-e053-2995a90ad259 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Regul Oil | PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT | ANUBIS COSMETICS SL | eb7c418b-8bee-26a3-e053-2a95a90a4e96 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Total Hydrating | BETAINE, GLYCERIN, POLYSORBATE 20 | ANUBIS COSMETICS SL | eaefe3b9-9064-18b1-e053-2a95a90a5765 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona New Even | LACTIC ACID, CITRIC ACID, GLYCOLIC ACID | ANUBIS COSMETICS SL | eaeeb6e0-5322-20c4-e053-2995a90a9fd9 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Vital Line | HYDROLYZED COLLAGEN | ANUBIS COSMETICS SL | f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 | 2023-08-29 | Warnings | 059QF0KO0R |
| Bacteriostatic Water | WATER | Medical Purchasing Solutions, LLC | 69485218-9343-952d-e053-2a91aa0ad4e8 | 2023-05-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | STERILE WATER | Hikma Pharmaceuticals USA Inc. | b20a28b0-7dfa-42eb-9177-ec256d5a5ef7 | 2023-05-08 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Civica, Inc. | 3f49eedf-5bf5-4a95-b704-c956d860ca04 | 2023-04-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Treprostinil | TREPROSTINIL | Sandoz Inc | 473297ca-a872-4052-a053-87dc8f0d3c13 | 2023-04-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Insulin Diluting Medium for NovoLog | WATER INJECTION | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.