FDA.reportPublic FDA data

NDC 63323-579-01 - SINCALIDE

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
63323-579
Requested NDC
63323-579-01
Package NDCs from labels
63323-579-01, 63323-579-05
Manufacturer
Fresenius Kabi USA, LLC | Bracco Diagnostics Inc.
Effective date
2024-01-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SINCALIDE - Fresenius Kabi USA, LLC | Bracco Diagnostics Inc.Fresenius Kabi USA, LLC | Bracco Diagnostics Inc.2024-01-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-579-01SINCALIDE5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,53
63323-579-05SINCALIDE10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-579SINCALIDE (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, 2 package rows20240131_bb5057da-8568-49b9-947d-fab7d8d8f257.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-579-01EA - Each63323-5796dae431e-c79f-4283-8c6b-d0fae4feb60b12023-06-06
63323-579-05EA - Each63323-579d639c8ca-4661-4dae-8937-a7213621a94612023-06-06

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 9 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM199BRYONIA, COLOCYNTHIS, KALI PHOS, NUX VOMICA, GUAICUMBestmade Natural Products2ef6896e-2a46-d146-e063-6294a90a79b22025-02-25WarningsExact identifier
unii: CI71S98N1Z
KALI PHOSPHORICUM 6XKALI PHOSPHORICUMSEVENE USAff0f631a-6065-6bc8-e053-6394a90ac3c82025-02-11WarningsExact identifier
unii: CI71S98N1Z
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BM130BELLADONNA, CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS, THUJABestmade Natural Products2dcfe9c0-c677-541f-e063-6294a90a078a2025-02-10WarningsExact identifier
unii: CI71S98N1Z
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: CI71S98N1Z
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: CI71S98N1Z
Nervousness - AnxietyPASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.Newton Laboratories, Inc.9c5db752-11bb-01c0-e053-2a95a90aa7312025-02-07WarningsExact identifier
unii: CI71S98N1Z
Nervousness - AnxietyPASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.Newton Laboratories, Inc.9c94ff3a-2451-3617-e053-2a95a90a7cb92025-02-07WarningsExact identifier
unii: CI71S98N1Z
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.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: CI71S98N1Z
Kali Phosphoricum Kit RefillPOTASSIUM PHOSPHATE, DIBASICWashington Homeopathic Productse958bb10-2ae8-7b22-e053-2a95a90affd52025-01-28WarningsExact identifier
unii: CI71S98N1Z
WHP StressARSENIC TRIOXIDE - DIBASIC POTASSIUM PHOSPHATE - PASSIFLORA INCARNATA FLOWERING TOP - DELPHINIUM STAPHISAGRIA SEEDWashington Homeopathic Products06e4315a-2ffa-a0f8-e063-6394a90a7fa02025-01-28WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BM50BARYTA CARB, CALC PHOS, FERRUM PHOS, KALI PHOS, MAGNESIA PHOS, NATRUM PHOS, PITUITRINUMBestmade Natural Products2c648fa0-e1e8-e3e7-e063-6294a90ad1b82025-01-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products Bio1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Productse9fb280b-2f79-f268-e053-2995a90a732c2025-01-22WarningsExact identifier
unii: CI71S98N1Z
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: CI71S98N1Z
MetoxALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Deseret Biologicals, Inc.deeae030-c266-44ab-8bc7-32c3292c72472025-01-17WarningsExact identifier
unii: AE28F7PNPL
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: CI71S98N1Z
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-74TRIBASIC CALCIUM PHOSPHATE, CAUSTICUM, FERROSOFERRIC PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, ANEMONE PRATENSIS, AND SEPIA OFFICINALIS JUICEDNA Labs, Inc.5f3afcfe-7494-46be-affa-4a1a8ec3616f2025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-76LOBELIA INFLATA, STRYCHNOS IGNATII SEED, AVENA SATIVA FLOWERING TOP, DIBASIC POTASSIUM PHOSPHATE, SELENICEREUS GRANDIFLORUS STEM, GLUTAMINE, TAURINE, AND THIAMINE HYDROCHLORIDEDNA Labs, Inc.ea7aadf5-0ee2-4b0a-9ba8-0a5d98944bd12025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-54DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICEDNA Labs, Inc.68a206a8-6f66-4957-843c-4c4c0636e78f2025-01-13WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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