FDA.reportPublic FDA data

NDC 65219-281-05 - 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
65219-281-05
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 1 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
gadobutrolGADOBUTROLZydus Pharmaceuticals USA Inc.4ea8ae43-22ca-40c0-be72-c91a321cafd12026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
gadobutrolGADOBUTROLViwit Pharmaceutical Co., Ltd.18c67a70-0c1f-46d4-a123-66080090b71b2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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