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 |
|---|---|---|---|---|---|---|
| Leader Eye Wash | PURIFIED WATER | Cardinal Health | 8d3ad11f-1945-f838-e053-2995a90a7aa5 | 2023-12-23 | Warnings | 059QF0KO0R |
| Rugby Eye Wash | WATER, PURIFIED | Rugby Laboratories | 1fee974b-4c29-4965-bd3d-da5e219eb13a | 2023-12-20 | Warnings | 059QF0KO0R |
| Eye Wash | WATER | Jiangxi Zhenmei Biological Technology Co.,Ltd | c68795b8-bf68-0d01-e053-2a95a90abebb | 2023-12-04 | Warnings | 059QF0KO0R |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | AZELAIC ACID, SALICYLIC ACID | ANUBIS COSMETICS SL | ebf3153d-30f5-54e4-e053-2995a90a74b1 | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID | ANUBIS COSMETICS SL | eca95dde-cb57-2ab6-e053-2995a90af84f | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | 059QF0KO0R |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | DMAE, ZIRHAFIRM | ANUBIS COSMETICS SL | f2274f8c-08aa-eb02-e053-2a95a90a3998 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN | ANUBIS COSMETICS SL | eb9244ea-6102-3cbe-e053-2a95a90ab8f6 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Vital Line | HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES | ANUBIS COSMETICS SL | ebe024f7-7c45-ad60-e053-2995a90a45d6 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL | ANUBIS COSMETICS SL | ebdddcec-f5da-51fe-e053-2995a90a6167 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Regul Oil | PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL | ANUBIS COSMETICS SL | eb8e5beb-4452-58c2-e053-2a95a90a66e0 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Protective Line | ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE | ANUBIS COSMETICS SL | ec83846f-11c0-8f59-e053-2995a90ab9d2 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Regul Oil | CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE | ANUBIS COSMETICS SL | eb68c3ab-7835-1a1c-e053-2995a90a0d66 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE | ANUBIS COSMETICS SL | eb53cba1-0509-43bc-e053-2995a90a5e09 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | FERULIC ACID, VITAMIN C, DMAE | ANUBIS COSMETICS SL | eaf0770c-795d-0232-e053-2a95a90ae0b5 | 2023-09-01 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.