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 2 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d39613-20bc-5877-e063-6394a90a0ee92026-06-09WarningsExact identifier
unii: CI71S98N1Z
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d5058d-861a-9e20-e063-6294a90a164c2026-06-09WarningsExact identifier
unii: CI71S98N1Z
BM Kali PhosKALI PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba9fff-c781-6f7e-e063-6394a90a2f142026-06-08WarningsExact identifier
unii: CI71S98N1Z
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: CI71S98N1Z
BM Kali Phos Icing SugarKALIUM PHOSPHORICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5355a81f-abab-18a4-e063-6394a90abce02026-06-03WarningsExact identifier
unii: CI71S98N1Z
Free RadicalACETALDEHYDE, ALFALFA, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBYL PALMITATE, COBALTUM METALLICUM, CYSTEINUM, DIMETHYL GLYCINE, FERRUM METALLICUM, FUCUS VESICULOSUS, GABA (GAMMA AMINOBUTYRIC ACID), GLUTATHIONE, HORDEUM VULGARE, L-METHIONINE, MAGNESIUM FLUORATUM, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, ORYZA SATIVA, QUERCETIN, RAPHANUS SATIVUS, SELENIUM METALLICUM, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, VITAMIN E, ZINC PICOLINATE, ZINCUM METALLICUMDeseret Biologicals, Inc.2408a38a-9cdd-48c0-b76c-b72e4fe5d7192026-06-02WarningsExact identifier
unii: AE28F7PNPL
BM KALI PHOS POTENCYKALI PHOSBM Private Limited532332ca-1a9a-d102-e063-6294a90a76c52026-05-31WarningsExact identifier
unii: CI71S98N1Z
Non-proprietary nameL- ARGININEXseer Pharmaceuticals3c6c0ac6-0d2a-b865-e063-6294a90aa3d22026-05-19WarningsExact identifier
unii: F7LTH1E20Y
TobaccotoxAVENA SATIVA, KALI PHOSPHORICUM, CACTUS GRANDIFLORUS, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, DAPHNE INDICA, MENTHOLUM, IGNATIA AMARA, NUX VOMICA, STAPHYSAGRIA, TABACUM, BENZINUM, NAPHTHALINUMBioActive Nutritional, Inc.b286c7fd-e456-49bf-bb82-0fd32eeb37232026-05-18WarningsExact identifier
unii: CI71S98N1Z
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: AE28F7PNPL
Free RadicalALFALFA, ASCORBYL PALMITATE, CYSTEINUM, DIMETHYL GLYCINE, FUCUS VESICULOSUS, HORDEUM VULGARE, L-METHIONINE, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, QUERCETIN, RAPHANUS SATIVUS, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, ALPHA-LIPOICUM ACIDUM, GABA (GAMMA AMINOBUTYRIC ACID), ORYZA SATIVA, VITAMIN E, ZINC PICOLINATE, COBALTUM METALLICUM, FERRUM METALLICUM, GLUTATHIONE, MAGNESIUM FLUORATUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUMDeseret Biologicals, Inc.36060680-f0d2-44c3-82fa-649e6e9d454d2026-05-06WarningsExact identifier
unii: AE28F7PNPL
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: CI71S98N1Z
H-Calm FormulaACONITUM NAPELLUS, ALFALFA, AVENA SATIVA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS VITALBA, FLOS, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHORICUM, LILIUM TIGRINUM, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, PULSATILLA, VALERIANA OFFICINALISHealing Natural Oils LLC4ee311e9-626a-a73c-e063-6294a90a773b2026-04-07WarningsExact identifier
unii: CI71S98N1Z
CerebraplexAVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, HYDROCOTYLE ASIATICA, POLYGONUM MULTIFLORUM, ROSMARINUS OFFICINALIS, VINCA MINOR, CEREBRUM SUIS, BARYTA CARBONICA, BELLADONNA, GERMANIUM SESQUIOXIDE, KALI PHOSPHORICUM, STRAMONIUMBioActive Nutritional, Inc.38905213-f20b-45d5-8e65-5f32e3839ea72026-03-27WarningsExact identifier
unii: CI71S98N1Z
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: CI71S98N1Z
AttendAVENA SATIVA, ARGENTUM NITRICUM, CAFFEINUM, HYOSCYAMUS NIGER, HYPOTHALAMUS SUIS, HUMULUS LUPULUS, IGNATIA AMARA, IODIUM, KALI PHOSPHORICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICANaturalCaref1592f5d-17b6-4a30-83bb-a34c6c2920f32026-03-25WarningsExact identifier
unii: CI71S98N1Z
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USA70c7710c-a354-4941-bd46-e64d6ea6b5dc2026-03-20Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: CI71S98N1Z
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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