FDA.reportPublic FDA data

NDC 0121-0977-55 - Cefotan

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
0121-0977
Requested NDC
0121-0977-55
Package NDCs from labels
0121-0977-55, 0121-0977-10
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2024-04-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefotan - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2024-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0977-10Cefotan10 in 1 TRAYINJECTION, POWDER, FOR SOLUTION106
0121-0977-55Cefotan20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0977CEFOTAN (CEFOTETAN) INJECTION, POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, 2 package rows20240410_f1510f5e-d001-44e0-accb-27cf79fd4f9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0977-10EA - Each0121-097721dfc7a1-0cf7-45a7-aaa5-e4441dd07daa12024-05-16
0121-0977-55EA - Each0121-09773a2f77c8-3859-477b-8740-6934ad77e2bd12024-05-16

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 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefotetanCEFOTETAN DISODIUMFresenius Kabi USA, LLCbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1722919
rxcui: 1722921
unii: 0GXP746VXB
CefotetanCEFOTETANHikma Pharmaceuticals USA Inc.33b13b93-58ce-44c7-b9a2-af3b3a333f802024-04-11Warnings, Adverse reactionsExact identifier
rxcui: 1722919
rxcui: 1722921
CefotanCEFOTETANPAI Holdings, LLC dba PAI Pharmaf1510f5e-d001-44e0-accb-27cf79fd4f9a2024-04-08Warnings, Adverse reactionsExact identifier
application number: NDA050588
ndc (package): 0121-0977-10
ndc (package): 0121-0976-10
ndc (package): 0121-0977-55
ndc (package): 0121-0976-55
ndc (product): 0121-0977
ndc (product): 0121-0976
ndc11 (package): 00121097755
rxcui: 1731542
rxcui: 1722919
rxcui: 1743557
rxcui: 1722921
spl id: 7e29cb53-c401-49b0-9b47-209601f7ec55
spl set id: f1510f5e-d001-44e0-accb-27cf79fd4f9a
unii: 0GXP746VXB

Reported adverse events (FAERS/openFDA)#

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