FDA.reportPublic FDA data

NDC 63323-237-01 - CEFAZOLIN

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
63323-237
Requested NDC
63323-237-01
Package NDCs from labels
63323-237-01, 63323-237-10
Manufacturer
Fresenius Kabi USA, LLC | ACS Dobfar SpA
Effective date
2023-09-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CEFAZOLIN - Fresenius Kabi USA, LLC | ACS Dobfar SpAFresenius Kabi USA, LLC | ACS Dobfar SpA2023-09-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-237-01CEFAZOLIN3 mL in 1 VIALPOWDER, FOR SOLUTION38
63323-237-10CEFAZOLIN25 in 1 CARTONPOWDER, FOR SOLUTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-237CEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20231019_c47c8d14-1eef-40f9-9d11-f0c300b1d4be.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-237-10EA - Each63323-2378ca6489e-d684-4f7b-a91f-23ede5a7fb1d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.06091653-e568-4e82-acc7-aefbce16de172024-04-18Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINQilu Pharmaceutical Co., Ltd.e8bd9e95-8af5-416b-b58c-e1dbe3d052ac2023-12-18Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINApotex Corp.37a626aa-96dc-4c4d-bfbc-be4f328f918b2023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINApotex Corp.0e8d4462-7642-4296-a605-6c1493e91ffd2023-12-14Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINApotex Corp.81d1783a-2baa-4d65-856a-f5ce38d248042023-12-14Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CEFAZOLINCEFAZOLIN SODIUMFresenius Kabi USA, LLCc47c8d14-1eef-40f9-9d11-f0c300b1d4be2023-09-27Warnings, Adverse reactionsExact identifier
application number: ANDA065303
ndc (package): 63323-236-10
ndc (package): 63323-237-01
ndc (package): 63323-237-10
ndc (package): 63323-236-01
ndc (product): 63323-237
ndc (product): 63323-236
ndc11 (package): 63323023701
rxcui: 1665052
rxcui: 1665050
spl id: 321ffc80-ee94-4a86-8c33-e966438d9fbb
spl set id: c47c8d14-1eef-40f9-9d11-f0c300b1d4be
unii: P380M0454Z
CefazolinCEFAZOLINA-S Medication Solutions8a772acc-726d-40e6-88ee-b6075cbf9b282023-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINMedical Purchasing Solutions, LLC6673be13-4c74-70b9-e053-2a91aa0a211d2023-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINMedical Purchasing Solutions, LLC79787707-c84f-f229-e053-2a91aa0a1f162023-05-16Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINProficient Rx LPd24529e3-e2b4-46d6-81ba-b7da745017922022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINSandoz Ince58f87fb-a47d-4081-a454-e4e916e2f6292020-09-08Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLIN SODIUMFresenius Kabi USA, LLC47a8928f-708d-418a-829b-36eded96bac02020-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P380M0454Z

Reported adverse events (FAERS/openFDA)#

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