NDC 63323-346-01 - Ceftriaxone

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
63323-346
Requested NDC
63323-346-01
Package NDCs from labels
63323-346-01, 63323-346-10
Manufacturer
Fresenius Kabi USA, LLC | ACS Dobfar SPA
Effective date
2023-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ceftriaxone - Fresenius Kabi USA, LLC | ACS Dobfar SPAFresenius Kabi USA, LLC | ACS Dobfar SPA2023-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-346-01Ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION16
63323-346-10Ceftriaxone25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-346CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20231021_7ea1db43-40fa-417b-8911-ae98092070a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-346-01EA - Each63323-346958072ed-1f1b-4ffb-95e1-02bc390ff67612024-04-05
63323-346-10EA - Each63323-34695eca02f-82c1-4c6f-9e98-6d7ab28be09b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS , LLC]1
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS , LLC]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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c2024-01-31Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutionsff8e830a-c288-46fb-9e19-ec2017943c072024-01-31Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
ceftriaxoneCEFTRIAXONESagent Pharmaceuticals5cf93bc5-9e4c-4734-bc02-c7d0ac0710222023-11-08Warnings, Adverse reactionsExact identifier
application number: ANDA065329
rxcui: 1665046
rxcui: 1665005
rxcui: 1665021
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONEFresenius Kabi USA, LLC7ea1db43-40fa-417b-8911-ae98092070a02023-09-30Warnings, Adverse reactionsExact identifier
application number: ANDA065329
ndc (package): 63323-346-10
ndc (package): 63323-345-10
ndc (package): 63323-347-20
ndc (package): 63323-347-01
ndc (package): 63323-346-01
ndc (product): 63323-345
ndc (product): 63323-346
ndc (product): 63323-347
ndc11 (package): 63323034601
rxcui: 1665046
rxcui: 1665005
rxcui: 1665021
spl id: 27777645-c5ae-4c89-abaf-ddb62dc7b859
spl set id: 7ea1db43-40fa-417b-8911-ae98092070a0
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMAsclemed USA, Inc.f01cf0e5-caaf-4759-ba21-50f3aceff5232023-09-02Warnings, Adverse reactionsExact identifier
rxcui: 1665005
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMApotex Corp.5116231f-82d1-44be-b08e-560c9a50e5c52023-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1665046
rxcui: 1665005
rxcui: 1665021
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMApotex Corp.ac03a72c-0e35-40f9-b7fc-081badb5f19c2023-01-28Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONE SODIUMSamson Medical Technologies, LLC5cd2d96f-83e5-4326-ae87-d0ede4ba493a2023-01-15Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONEProficient Rx LPfcf401df-bcdc-4773-a63b-9741c0f74b3d2022-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA065329
rxcui: 1665046
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LPa25ab5ea-c46d-4562-8f7e-0ccffc2ab0692022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 1665046
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP42ba7a9d-7d2b-4eac-af59-897151a8c9242022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 1665021
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc9d1f630b-e759-4395-9d01-ddc90e4fea752022-03-09Warnings, Adverse reactionsExact identifier
rxcui: 1665046
rxcui: 1665021
unii: 023Z5BR09K
CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.67153914-16bc-490d-82d7-6380616184672022-01-13Warnings, Adverse reactionsExact identifier
rxcui: 1665046
rxcui: 1665021
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONEHikma Pharmaceuticals USA Inc.1f8776bd-4f5b-427a-849a-6b8338f7997d2019-04-24Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K

Reported adverse events (FAERS/openFDA)#

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