FDA.reportPublic FDA data

NDC 0781-3451-70 - 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
0781-3451
Requested NDC
0781-3451-70
Package NDCs from labels
0781-3451-70, 0781-3451-96, 0781-3451-95
Manufacturer
Sandoz Inc
Effective date
2025-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefazolin - Sandoz IncSandoz Inc2025-02-05HUMAN 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
0781-3451-70Cefazolin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION119
0781-3451-95Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1019
0781-3451-96Cefazolin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3451CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]18Current NDC, Legacy NDC, 3 package rows20241218_18e7366a-1b3e-4010-8f4a-dd559d4f2146.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3451-70EA - Each0781-3451fd19e2c6-ac4c-4b95-820c-cf6729e1e1c412012-07-24
0781-3451-95EA - Each0781-34519a4d0156-0c96-43d9-b915-ce95df0c599412026-03-17
0781-3451-96EA - Each0781-34512f8aed59-d555-4962-985f-e2441005291f12012-07-24

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 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.26de1ce9-06a9-486f-b27d-2ac635f018d12026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINCivica, Inc.9ea55207-6d86-401e-b9b9-73c9534a233f2026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.1dc9de56-e259-4546-a1db-23119a8a088e2026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 1665052
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINWG Critical Care, LLC4f3a9248-a354-4c77-bf5b-9eed38f002192026-02-27Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINWG Critical Care, LLC00dd6da7-50a8-44c9-b2dc-7948973df3922026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINCivica, Inc.c24e604f-16ca-4945-8e9d-277cc67a8c682025-11-20Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINCivica, Inc.1367568c-7d27-479f-a4c5-58e99942f6862025-11-01Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CEFAZOLINCEFAZOLINHenry Schein, Inc.197d5702-2c20-480e-8246-4d0d21f871be2025-10-27WarningsExact identifier
rxcui: 1665050
unii: P380M0454Z
CEFAZOLINCEFAZOLINHenry Schein, Inc.5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b2025-10-27Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINProPharma Distribution3d5cc73c-8a41-b285-e063-6294a90a609f2025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.570d2583-9ce7-4941-bf7c-6ebc783c0f2b2025-07-25Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINApotex Corp.0422fe47-c372-494f-bac2-612f550b44a42025-07-15Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINWG Critical Care, LLCf17160d4-fc42-4f9c-abb8-d04f01ae6dd12025-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1665052
rxcui: 1665050
unii: P380M0454Z
Cefazolin SodiumCEFAZOLIN SODIUMB. Braun Medical Inc.17f8f038-c204-4dab-80d7-6f7ac41ddbec2025-03-10Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
CefazolinCEFAZOLINSandoz Inc18e7366a-1b3e-4010-8f4a-dd559d4f21462025-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA062831
ndc (package): 0781-3451-96
ndc (package): 0781-3450-70
ndc (package): 0781-3450-95
ndc (package): 0781-3451-95
ndc (package): 0781-3451-70
ndc (product): 0781-3451
ndc (product): 0781-3450
ndc11 (package): 00781345170
rxcui: 1665052
rxcui: 1665050
spl id: 05cd44b2-275f-44f5-b4f8-22393df834a1
spl set id: 18e7366a-1b3e-4010-8f4a-dd559d4f2146
unii: P380M0454Z
CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.cf13db9c-d8a1-489f-9aa0-fc70839d4bbc2025-01-08Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.6c7761d3-c154-4802-9876-627cd42913f02024-12-31Warnings, Adverse reactionsExact identifier
unii: P380M0454Z
Cefazolin SodiumCEFAZOLIN SODIUMDirect_rx22dfc2e4-07a7-8d13-e063-6394a90a3e9f2024-09-24Warnings, Adverse reactionsExact identifier
rxcui: 1665050
unii: P380M0454Z
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

Reported adverse events (FAERS/openFDA)#

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