FDA.reportPublic FDA data

NDC 50419-342-15 - Ultravist

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
50419-342
Requested NDC
50419-342-15
Package NDCs from labels
50419-342-41, 50419-342-10, 50419-342-05, 50419-342-43, 50419-342-21, 50419-342-15
Manufacturer
Bayer HealthCare Pharmaceuticals Inc. | Bayer AG
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ultravist - Bayer HealthCare Pharmaceuticals Inc. | Bayer AGBayer HealthCare Pharmaceuticals Inc. | Bayer AG2026-03-02HUMAN PRESCRIPTION DRUG LABEL
UltravistBayer HealthCare Pharmaceuticals Inc. | Bayer AG | Sharp Corporation | Quality Packaging Specialists International LLC2023-04-25HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-342-05Ultravist10 in 1 CARTONINJECTION1025
50419-342-05Ultravist50 mL in 1 VIAL, GLASSINJECTION5025
50419-342-10Ultravist10 in 1 CARTONINJECTION1025
50419-342-10Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-342-21Ultravist200 mL in 1 BOTTLEINJECTION20025
50419-342-21Ultravist10 in 1 PACKAGEINJECTION1025
50419-342-41Ultravist50 mL in 1 VIAL, GLASSINJECTION5025
50419-342-41Ultravist10 in 1 CARTONINJECTION1025
50419-342-43Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-342-43Ultravist10 in 1 CARTONINJECTION1025
50419-342-21Ultravist10 in 1 PACKAGEINJECTION1022
50419-342-21Ultravist200 mL in 1 BOTTLEINJECTION20022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-342ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Legacy NDC, 10 package rows20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip
50419-342ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Legacy NDC, 2 package rows20230515_d96a7883-d160-40a1-bdbd-2e8d7877cd18.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-342-05ML - Milliliter50419-342ca74ffd8-d4f2-4f3b-b526-ab8fa9d7d3eb12012-07-24
50419-342-10ML - Milliliter50419-3428edc0952-df59-4ec6-848b-6e6f9c0e6b0312012-07-24
50419-342-15ML - Milliliter50419-342756061c0-ced4-45d1-a272-600b8104da5d12013-03-03
50419-342-21ML - Milliliter50419-34234408919-d699-4b02-8ee1-8e414e1028da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOPROMIDEACTIVE INGREDIENT712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
IOPROMIDEACTIVE MOIETY712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
IOPROMIDEACTIVE INGREDIENT712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
IOPROMIDEACTIVE MOIETY712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
UltravistIOPROMIDEBayer HealthCare Pharmaceuticals Inc.df917c3a-59a2-4ed1-8470-8a5394c733252026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020220
ndc (package): 50419-348-10
ndc (package): 50419-344-21
ndc (package): 50419-342-21
ndc (package): 50419-347-20
ndc (package): 50419-344-58
ndc (package): 50419-347-05
ndc (package): 50419-346-58
ndc (package): 50419-346-43
ndc (package): 50419-344-12
ndc (package): 50419-346-10
ndc (package): 50419-344-32
ndc (package): 50419-342-10
ndc (package): 50419-348-12
ndc (package): 50419-346-97
ndc (package): 50419-342-05
ndc (package): 50419-348-20
ndc (package): 50419-344-10
ndc (package): 50419-346-41
ndc (package): 50419-346-05
ndc (package): 50419-348-13
ndc (package): 50419-348-05
ndc (package): 50419-344-91
ndc (package): 50419-344-65
ndc (package): 50419-346-15
ndc (package): 50419-344-07
ndc (package): 50419-346-32
ndc (package): 50419-346-28
ndc (package): 50419-344-41
ndc (package): 50419-348-11
ndc (package): 50419-342-41
ndc (package): 50419-346-65
ndc (package): 50419-346-33
ndc (package): 50419-346-26
ndc (package): 50419-346-12
ndc (package): 50419-346-20
ndc (package): 50419-346-07
ndc (package): 50419-344-15
ndc (package): 50419-342-43
ndc (package): 50419-346-91
ndc (package): 50419-346-45
ndc (package): 50419-344-48
ndc (package): 50419-348-21
ndc (package): 50419-344-43
ndc (package): 50419-344-05
ndc (package): 50419-344-97
ndc (package): 50419-344-23
ndc (product): 50419-346
ndc (product): 50419-347
ndc (product): 50419-342
ndc (product): 50419-348
ndc (product): 50419-344
spl id: 4314fa34-edbc-44f3-b40b-277c6fbd2ab0
spl set id: df917c3a-59a2-4ed1-8470-8a5394c73325
unii: 712BAC33MZ
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
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Edetate Calcium DisodiumEDETATE CALCIUM DISODIUMRising Pharma Holdings, Inc.710a2c8c-3620-4f6f-b8fc-fb19ab9e9f222025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 25IH6R4SGF
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
TROMETHAMINETROMETHAMINEB. Braun Medical Inc.57db5686-7f7f-4999-87e3-e1cbbda4a98d2024-12-23Warnings, Adverse reactionsExact identifier
unii: 023C2WHX2V
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: QTT17582CB
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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