FDA.reportPublic FDA data

NDC 70436-213-33 - 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
70436-213
Requested NDC
70436-213-33
Package NDCs from labels
70436-213-33, 70436-213-82
Manufacturer
Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd.
Effective date
2025-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
gadobutrol - Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd.Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd.2025-04-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-213-33gadobutrol10 mL in 1 VIAL, SINGLE-DOSEINJECTION104
70436-213-82gadobutrol10 in 1 CARTONINJECTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-213GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC]4Current NDC, 2 package rows20250419_832e0ae1-4fe1-4dff-9978-c9200bcebb55.zip

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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
THAMTROMETHAMINEHospira, Inc.4af52118-c12b-4ad5-30bb-959848357e8a2026-05-27Warnings, Adverse reactionsExact identifier
unii: 023C2WHX2V
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
GadavistGADOBUTROLBayer HealthCare Pharmaceuticals Inc.3c5101a0-0c7e-4078-8dc3-a57beb9a0e922026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
GadavistGADOBUTROLBayer HealthCare Pharmaceuticals Inc.b7afe34d-b70f-41a5-b89c-561bdf29f0462026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
GadavistGADOBUTROLBayer HealthCare Pharmaceuticals Inc.bd28560f-de4d-4140-874e-31df823f4dbb2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
TromethamineTROMETHAMINEMILLA PHARMACEUTICALS INC.082b1104-502b-47af-95bf-0dbf2422990e2026-01-07Warnings, Adverse reactionsExact identifier
unii: 023C2WHX2V
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
GadobutrolGADOBUTROLFresenius Kabi USA, LLCc0dd1618-0bb3-4974-846b-e5afc2311ae62025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
GadobutrolGADOBUTROLFresenius Kabi USA, LLC007696d0-4b62-4937-9640-4ad619504df42025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1BJ477IO2L
gadobutrolGADOBUTROLSlate Run Pharmaceuticals, LLC52fbda34-9974-4f9f-9749-6b17d0495b622025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217480
unii: 1BJ477IO2L
gadobutrolGADOBUTROLSlate Run Pharmaceuticals, LLC832e0ae1-4fe1-4dff-9978-c9200bcebb552025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217480
ndc (package): 70436-214-34
ndc (package): 70436-213-82
ndc (package): 70436-218-30
ndc (package): 70436-212-32
ndc (package): 70436-214-54
ndc (package): 70436-213-33
ndc (package): 70436-212-54
ndc (package): 70436-214-80
ndc (package): 70436-212-80
ndc (package): 70436-218-84
ndc (product): 70436-213
ndc (product): 70436-212
ndc (product): 70436-218
ndc (product): 70436-214
ndc11 (package): 70436021333
spl id: 3304f07e-e137-e806-e063-6394a90a8a4a
spl set id: 832e0ae1-4fe1-4dff-9978-c9200bcebb55
unii: 1BJ477IO2L
gadobutrolGADOBUTROLSlate Run Pharmaceuticals, LLC4af6ee2b-d039-497f-a8f0-bdf948e5f54e2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217480
unii: 1BJ477IO2L
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB