FDA.reportPublic FDA data

NDC 65219-281-08 - Gadobutrol

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
65219-281
Requested NDC
65219-281-08
Package NDCs from labels
65219-281-00, 65219-281-02, 65219-281-03, 65219-281-07, 65219-281-08, 65219-281-10, 65219-281-05, 65219-281-15
Manufacturer
Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
Effective date
2025-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GadobutrolFresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)2025-07-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-281-00Gadobutrol2 mL in 1 VIAL, SINGLE-DOSEINJECTION23
65219-281-02Gadobutrol3 in 1 CARTONINJECTION33
65219-281-02Gadobutrol5 in 1 BOXINJECTION53
65219-281-03Gadobutrol7.5 mL in 1 VIAL, SINGLE-DOSEINJECTION7.53
65219-281-05Gadobutrol15 mL in 1 VIAL, SINGLE-DOSEINJECTION153
65219-281-07Gadobutrol10 in 1 CARTONINJECTION103
65219-281-07Gadobutrol2 in 1 BOXINJECTION23
65219-281-08Gadobutrol10 mL in 1 VIAL, SINGLE-DOSEINJECTION103
65219-281-10Gadobutrol10 in 1 CARTONINJECTION103
65219-281-10Gadobutrol2 in 1 BOXINJECTION23
65219-281-15Gadobutrol10 in 1 CARTONINJECTION103
65219-281-15Gadobutrol2 in 1 BOXINJECTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-281GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC]2Current NDC, 12 package rows20250119_007696d0-4b62-4937-9640-4ad619504df4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-281-00ML - Milliliter65219-281273c0413-88f9-4927-970f-5828015629a212023-08-08
65219-281-02ML - Milliliter65219-281940a2b60-1fab-41ce-82d4-15220f38969112023-08-08
65219-281-03ML - Milliliter65219-281a4279d8f-cf98-4527-b747-9e196c1844a412023-08-08
65219-281-05ML - Milliliter65219-28117da6f10-18c3-4d3d-bbae-3f715f703eb112023-08-08
65219-281-07ML - Milliliter65219-281b7d8a359-61db-4ded-a1e2-3c40eea22a5d12023-08-08
65219-281-08ML - Milliliter65219-2811d458f43-36a1-4389-b635-1a91762ba07812023-08-08
65219-281-10ML - Milliliter65219-28199027c20-79d7-4c70-bfa9-78ad46fc19ca12023-08-08
65219-281-15ML - Milliliter65219-2818980610e-44fb-43a8-8815-31a9866d08f012023-08-08

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 4 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GadobutrolGADOBUTROLFresenius Kabi USA, LLCc0dd1618-0bb3-4974-846b-e5afc2311ae62025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.