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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
| Bio Rock Water | ROCK WATER | BioActive Nutritional, Inc. | 178bd16d-0d4f-49d8-866b-8ab3a3c6889d | 2018-07-30 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye Wash | WATER | CVS Pharmacy | 049cee29-7ec2-4d5b-8308-f522acde43a7 | 2017-03-29 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.