FDA.reportPublic FDA data

NDC 0781-3452-46 - 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
0781-3452
Requested NDC
0781-3452-46
Package NDCs from labels
0781-3452-46, 0781-3452-95
Manufacturer
Sandoz Inc
Effective date
2020-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefazolin - Sandoz IncSandoz Inc2020-09-08HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3452-46Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION118
0781-3452-95Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3452CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]18Current NDC, Legacy NDC, 2 package rows20241215_e58f87fb-a47d-4081-a454-e4e916e2f629.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3452-46EA - Each0781-34525e43cd9a-858d-432f-974a-1dcee86d7e8f12012-07-24
0781-3452-95EA - Each0781-3452f5bed9a6-1b5d-4805-8156-2af516a3029f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12

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 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefazolinCEFAZOLINApotex Corp.37a626aa-96dc-4c4d-bfbc-be4f328f918b2023-12-15Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINApotex Corp.0e8d4462-7642-4296-a605-6c1493e91ffd2023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 313920
unii: P380M0454Z
CefazolinCEFAZOLINApotex Corp.81d1783a-2baa-4d65-856a-f5ce38d248042023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 313920
unii: P380M0454Z
CEFAZOLINCEFAZOLIN SODIUMFresenius Kabi USA, LLCc47c8d14-1eef-40f9-9d11-f0c300b1d4be2023-09-27Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINA-S Medication Solutions8a772acc-726d-40e6-88ee-b6075cbf9b282023-06-23Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINMedical Purchasing Solutions, LLC6673be13-4c74-70b9-e053-2a91aa0a211d2023-06-01Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINMedical Purchasing Solutions, LLC79787707-c84f-f229-e053-2a91aa0a1f162023-05-16Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINProficient Rx LPd24529e3-e2b4-46d6-81ba-b7da745017922022-08-01Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINSandoz Ince58f87fb-a47d-4081-a454-e4e916e2f6292020-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA062831
ndc (package): 0781-3452-46
ndc (package): 0781-3452-95
ndc (product): 0781-3452
ndc11 (package): 00781345246
rxcui: 313920
spl id: c888c95b-df82-4261-854e-f74f9b2179e1
spl set id: e58f87fb-a47d-4081-a454-e4e916e2f629
unii: P380M0454Z
CefazolinCEFAZOLIN SODIUMFresenius Kabi USA, LLC47a8928f-708d-418a-829b-36eded96bac02020-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313920
unii: P380M0454Z

Reported adverse events (FAERS/openFDA)#

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