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 8 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO7 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULPHBestmade Natural Products3022c9be-81b2-6362-e063-6294a90abf152025-03-12WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO8 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, KALI SULPH, NAT SULPHBestmade Natural Products3022ecf2-c8bb-8845-e063-6294a90a82a32025-03-12WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO9 Lactose FreeFERR PHOS, KALI MUR, KALI PHOS, MAG PHOSBestmade Natural Products302320d8-5ef8-a82a-e063-6294a90a7ea62025-03-12WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO24CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSBestmade Natural Products300e1e77-f1dc-03fa-e063-6294a90a106e2025-03-11WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO8CAL PHOS, FERR PHOS, KALI PHOS, KALI SULPH, NAT SULPHBestmade Natural Products2ffe04ab-c216-a732-e063-6294a90ac37e2025-03-10WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO9FERR PHOS, KALI MUR, KALI PHOS, MAG PHOSBestmade Natural Products2ffe4c1a-7c14-d3d1-e063-6294a90a03792025-03-10WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products30002ebe-3b38-cb35-e063-6394a90a8f7e2025-03-10WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO1CALC PHOS FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products2fd724b6-c6cf-652a-e063-6294a90ab4d72025-03-08WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO2KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2fd794c0-a553-e3f5-e063-6294a90a522a2025-03-08WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products Kali PhosKALI PHOSPHORICUMBestmade Natural Products2f99ec14-f22e-7228-e063-6394a90a94f02025-03-05WarningsExact identifier
unii: CI71S98N1Z
Potassium PhosphatesPOTASSIUM PHOSPHATESCipla USA Inc.f1f26a17-d2e2-48f5-9054-8ee7e380556e2025-02-28Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BM212ARS ALB, KALI PHOS, NAT CARB, NITRIC ACIDBestmade Natural Products2f37416e-b3af-f980-e063-6294a90a6be12025-02-28WarningsExact identifier
unii: CI71S98N1Z
Potassium PhosphatesPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASICFresenius Kabi USA, LLC475f5cd7-45bd-412a-b419-9962585d6cda2025-02-28Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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