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 7 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetDetoxALLIUM 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, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Dr. Donna Restivo DC89ce5e89-c592-445e-92f9-365133005fb32025-05-23WarningsExact identifier
unii: AE28F7PNPL
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Adrenal TonicARALIA QUINQUEFOLIA, GLYCYRRHIZA GLABRA, SARSAPARILLA, AVENA SATIVA, GLANDULA SUPRARENALIS BOVINE, ADRENALINUM, ARSENICUM ALBUM, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, VERATRUM ALBUMBioActive Nutritional, Inc.2bbf65e2-47b9-46d3-a8de-69bc543783f82025-05-20WarningsExact identifier
unii: CI71S98N1Z
Jacksons Cell Salts KALI PHOS 6X 10KALI PHOSPHORICUMZettl Health Inc.3467dac6-887e-3677-e063-6294a90a21bb2025-05-05WarningsExact identifier
unii: CI71S98N1Z
Kali Phos 6XPOTASSIUM PHOSPHATE, DIBASICHyland's Inc.dbfe86e8-c06f-2a84-e053-2a95a90a1f3d2025-04-30WarningsExact identifier
unii: CI71S98N1Z
Potassium PhosphatesPOTASSIUM PHOSPHATESFresenius Kabi USA, LLC357c3020-ea6f-4401-a2e7-cebb82b031442025-04-15Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products Kali Phos 8xKALI PHOSPHORICUMBestmade Natural Products31e0616f-d471-fb29-e063-6294a90a30692025-04-03WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO15 Lactose FreeCALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, CALC SULPH, MAG PHOSBestmade Natural Products30365dcf-1e90-f81a-e063-6294a90a24f82025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO17 Lactose FreeCALC FLUOR, KALI PHOS, KALI MURBestmade Natural Products3036e6be-efc7-7b2b-e063-6294a90a3fdc2025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO15CALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, CALC SULPH, MAG PHOSBestmade Natural Products2ffff324-67c5-b1b5-e063-6394a90acb852025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO26 Lactose FreeMAG PHOS, CALC PHOS, KALI PHOS, CALC FLUORBestmade Natural Products303af4a2-7df3-1fc1-e063-6394a90ad4fc2025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO13CALC PHOS, KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products2fffab7f-0d4b-0e96-e063-6294a90a34d82025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO17CALC FLUOR, KALI PHOS, KALI MURBestmade Natural Products30006a9d-ece8-9c31-e063-6294a90a969a2025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO26MAG PHOS, CALC PHOS, KALI PHOS, CALC FLUORBestmade Natural Products300e6c83-2894-b0b0-e063-6394a90a5da92025-03-23WarningsExact identifier
unii: CI71S98N1Z
EMF Protect and BalanceALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA HISPANA, X-RAY, YTTERBIUM OXIDEDeseret Biologicals, Inc.00a2c1c7-2c04-4c71-9276-24ba87288d612025-03-17WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO24 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSBestmade Natural Products303a81d7-5f4e-e754-e063-6394a90a751f2025-03-13WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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