FDA.reportPublic FDA data

NDC 63304-941 - 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
63304-941
Package NDCs from labels
63304-941-10
Manufacturer
ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)
Effective date
2007-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefazolin for Injection USP "PHARMACY BULK PACKAGE- NOT FOR DIRECT INFUSION"ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)2007-10-25HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-941-10Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101
63304-941-10Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-941CEFAZOLIN (CEFAZOLIN) INJECTION, POWDER, FOR SOLUTION [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]12 package rows20071101_976916CA-85FA-4099-9607-FD377E9CF319.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-941-10EA - Each63304-941c3121ecb-94b0-462f-9232-1b9acc0b3f4b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cefazolin sodiumACTIVE INGREDIENTP380M0454ZCEFAZOLIN (CEFAZOLIN) INJECTION, POWDER, FOR SOLUTION [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
CefazolinACTIVE MOIETYIHS69L0Y4TCEFAZOLIN (CEFAZOLIN) INJECTION, POWDER, FOR SOLUTION [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1

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 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefazolinCEFAZOLINCivica, Inc.c24e604f-16ca-4945-8e9d-277cc67a8c682025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 313920
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.570d2583-9ce7-4941-bf7c-6ebc783c0f2b2025-07-25Warnings, Adverse reactionsExact identifier
rxcui: 313920
CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.cf13db9c-d8a1-489f-9aa0-fc70839d4bbc2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 313920
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.06091653-e568-4e82-acc7-aefbce16de172024-04-18Warnings, Adverse reactionsExact identifier
rxcui: 313920
CefazolinCEFAZOLINApotex Corp.0e8d4462-7642-4296-a605-6c1493e91ffd2023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 313920
CefazolinCEFAZOLINApotex Corp.81d1783a-2baa-4d65-856a-f5ce38d248042023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 313920
CefazolinCEFAZOLINSandoz Ince58f87fb-a47d-4081-a454-e4e916e2f6292020-09-08Warnings, Adverse reactionsExact identifier
rxcui: 313920
CefazolinCEFAZOLIN SODIUMFresenius Kabi USA, LLC47a8928f-708d-418a-829b-36eded96bac02020-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313920
2C82CE3F-C3C2-7314-6D97-7CB8DF759786976916CA-85FA-4099-9607-FD377E9CF3192007-10-25Warnings, Adverse reactionsExact identifier
spl id: 2C82CE3F-C3C2-7314-6D97-7CB8DF759786
spl set id: 976916CA-85FA-4099-9607-FD377E9CF319

Reported adverse events (FAERS/openFDA)#

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