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 1 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited98315c6e-308d-423b-a046-4be1f54d30ae2026-09-01Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited125121b8-bc4c-44ee-906e-e72f652a5aa62026-09-01Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
BMNP Kali PhosKALIUM PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5480dd-de27-9854-e063-6294a90a1f832026-08-31WarningsExact identifier
unii: CI71S98N1Z
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: CI71S98N1Z
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: AE28F7PNPL
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: CI71S98N1Z
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.63ce9942-a299-4d9b-b63b-35b297472dc92026-08-13WarningsExact identifier
unii: CI71S98N1Z
Adrenal-ToneADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.Energetix Corporation1ea4abb3-3a02-4d5c-baeb-d903b0febbb52026-08-11WarningsExact identifier
unii: CI71S98N1Z
Relax-ToneCALCAREA CARBONICA, COFFEA CRUDA, HUMULUS LUPULUS, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PASSIFLORA INCARNATE, PHOSPHORUS, PULSATILLA VULGARIS, STAPHYSAGRIA, VALERIANA OFFICINALISEnergetix Corporation85563888-8097-4af4-8ab1-b6d6e545b4992026-08-11WarningsExact identifier
unii: CI71S98N1Z
JetZone Jet Lag PreventionARNICA MONTANA, ANAMIRTA COCCULUS, POTASSIUM PHOSPHATE, GELSEMIUM SEMPERVIRENS, STRYCHNOS NUX VOMICA, SILVER NITRATEBelclare Corporation08f6270b-afbe-db8c-e063-6394a90a39862026-08-06WarningsExact identifier
unii: CI71S98N1Z
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: AE28F7PNPL
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: CI71S98N1Z
GLP-4TE HOMOAACG-A, AACG-B, ADENOSINUM CYCLOPHOSPHORICUM, BERBERINUM, CALCAREA CARBONICA, CINCHONA OFFICINALIS, CHOLINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, CURCUMA LONGA, METHYLCOBALAMIN, DNA, FERRUM METALLICUM, PANAX GINSENG, L-GLUTAMIC ACID, HEPAR SUIS, HYPOTHALAMUS SUIS, INDOLUM, INSULINUM (HUMAN), IODIUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, L-METHIONINE, PANCREAS SUIS, STOMACH (SUIS), ZINCUM METALLICUM, 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATEDeseret Biologicals, Inc.bb41a08a-e960-4364-a547-4ad356b2c36d2026-07-24WarningsExact identifier
unii: AE28F7PNPL
Potassium PhosphatesPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASICCIVICA, INC.f7702b2f-d0d1-4696-896d-571607fc0dc82026-07-10Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: AE28F7PNPL
BM BIO24 ICING SUGARCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro544b2bf9-74e8-297f-e063-6394a90a3dac2026-06-15WarningsExact identifier
unii: CI71S98N1Z
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: CI71S98N1Z
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: CI71S98N1Z
BM BIO15CALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, MAG PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d242d4-c900-f0aa-e063-6394a90a80c52026-06-09WarningsExact identifier
unii: CI71S98N1Z
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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