FDA.reportPublic FDA data

NDC 71083-0020-01 - NephroScan

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
71083-0020
Requested NDC
71083-0020-01
Package NDCs from labels
71083-0020-1, 71083-0020-5, 71083-0020-01
Manufacturer
Theragnostics Inc | ROTOP Pharmaka GmbH
Effective date
2024-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NephroScan - Theragnostics Inc | ROTOP Pharmaka GmbHTheragnostics Inc | ROTOP Pharmaka GmbH2024-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71083-0020-1NephroScan1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,15
71083-0020-5NephroScan5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71083-0020NEPHROSCAN (SUCCIMER) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAGNOSTICS INC]5Current NDC, Legacy NDC, 2 package rows20241004_ddd90c4a-5792-49c9-837f-710d1a604742.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 8 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FoliflexFERROUS FUMARATE, FOLIC ACIDPureTek Corporationcba98d1a-8cf9-39d9-e053-2995a90ae8bb2024-11-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FinazolFERROUS FUMARATE, FOLATEPureTek Corporation24290823-022a-433b-e063-6394a90a8fd02024-11-07Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: PQ6CK8PD0R
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: PQ6CK8PD0R
MetabolismBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ASCORBICUM ACIDUM, METHYLCOBALAMIN, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, GERMANIUM SESQUIOXIDE, CYSTEINUM, MANGANESE GLUCONATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), PYRUVIC ACID, UBIDECARENONUM, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.76f70259-44b1-467a-bff4-b427ddfe3abd2024-10-17WarningsExact identifier
unii: PQ6CK8PD0R
PrenatrylFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb364551b-2ccc-4db3-e053-2995a90afbbf2024-10-08Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: PQ6CK8PD0R
PrenatrixFERROUS FUMARATE, FOLIC ACIDPureTek Corporationae07585b-e6e4-fd6d-e053-2995a90a7eec2024-09-30Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
PretrateFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba4a1424-0782-77c0-e053-2a95a90a6e442024-09-30Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
NephroScanSUCCIMERTheragnostics Incddd90c4a-5792-49c9-837f-710d1a6047422024-09-29Warnings, Adverse reactionsExact identifier
application number: NDA214993
ndc (package): 71083-0020-5
ndc (package): 71083-0020-1
ndc (product): 71083-0020
ndc11 (package): 71083002001
spl id: ed28b4c6-15f3-495e-9e79-ce9610228aa5
spl set id: ddd90c4a-5792-49c9-837f-710d1a604742
unii: DX1U2629QE
DavimetMULTIVITAMINPureTek Corporatione4a57710-caa9-51e5-e053-2a95a90a8ad02024-09-13Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: PQ6CK8PD0R
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: PQ6CK8PD0R
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
Bio Tonsilla PhaseDULCAMARA, ECHINACEA (ANGUSTIFOLIA), AESCULUS HIPPOCASTANUM, ANTIMONIUM TARTARICUM, ASCORBICUM ACIDUM, COCCUS CACTI, GALIUM APARINE, GENTIANA LUTEA, GERANIUM ROBERTIANUM, PULSATILLA (PRATENSIS), SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, MANNOSE, CONIUM MACULATUM, LYMPH NODE (SUIS), SULPHUR, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, MEDULLA OSSIS SUIS, SPLEEN (SUIS), CORTISONE ACETICUM, GLANDULA SUPRARENALIS SUIS, MERCURIUS SOLUBILIS, THYROIDINUM (SUIS),Deseret Biologicals, Inc.74f899ed-8021-470a-995b-4822da412c502024-05-07WarningsExact identifier
unii: PQ6CK8PD0R
Prenatol-MMULTIVITAMINPureTek Corporation17559a44-94b7-9ca0-e063-6294a90a21232024-05-06Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Vitamin C 15 %L-ASCORBIC ACIDPURETEK CORPORATION11741b56-0fc4-f0d6-e063-6394a90ae6aa2024-05-06WarningsExact identifier
unii: PQ6CK8PD0R
Vitamin C 10 %L-ASCORBIC ACIDPURETEK CORPORATION1019e858-3d5f-64b5-e063-6394a90a6cf02024-05-06WarningsExact identifier
unii: PQ6CK8PD0R
Occuloplex GEUPHRASIA OFFICINALIS, GINKGO BILOBA, PETROSELINUM SATIVUM, VACCINIUM MYRTILLUS, ASCORBICUM ACIDUM, SPIGELIA ANTHELMIA, EYE (SUIS), GERMANIUM SESQUIOXIDE, UBIDECARENONUM, AURUM METALLICUM, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, PHOSPHORUS, RUTA GRAVEOLENS, SULPHUR, LITHIUM METALLICUMBioActive Nutritional, Inc.c982e701-129c-4b55-b8e6-ff05178384922024-05-02WarningsExact identifier
unii: PQ6CK8PD0R
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

Reported adverse events (FAERS/openFDA)#

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