FDA.reportPublic FDA data

NDC 63323-385-01 - Cefotetan

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
63323-385
Requested NDC
63323-385-01
Package NDCs from labels
63323-385-01, 63323-385-10
Manufacturer
Fresenius Kabi USA, LLC | ACS DOBFAR SPA
Effective date
2025-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefotetan - Fresenius Kabi USA, LLC | ACS DOBFAR SPAFresenius Kabi USA, LLC | ACS DOBFAR SPA2025-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-385-01Cefotetan10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION109
63323-385-10Cefotetan10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-385CEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20250116_bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-385-01EA - Each63323-3850b911497-6dc4-43e9-a30b-b148cceebdf312024-04-05
63323-385-10EA - Each63323-3855b0a02de-e9b4-4aac-b328-a9239bea1e5012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTETAN DISODIUMACTIVE INGREDIENT0GXP746VXBCEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
CEFOTETANACTIVE MOIETY48SPP0PA9QCEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4

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
application number: ANDA065374
ndc (package): 63323-386-20
ndc (package): 63323-385-01
ndc (package): 63323-386-01
ndc (package): 63323-385-10
ndc (product): 63323-385
ndc (product): 63323-386
ndc11 (package): 63323038501
rxcui: 1722919
rxcui: 1722921
spl id: a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8
spl set id: bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e
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
rxcui: 1722919
rxcui: 1722921
unii: 0GXP746VXB

Reported adverse events (FAERS/openFDA)#

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