FDA.reportPublic FDA data

NDC 0143-9768-01 - 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
0143-9768
Requested NDC
0143-9768-01
Package NDCs from labels
0143-9768-01, 0143-9768-46
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ceftriaxone for InjectionHikma Pharmaceuticals USA Inc.2019-12-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-9768-462020-09-27C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection
0143-9768-462020-09-25C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection
0143-9768-462020-07-22C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9768-01Ceftriaxone100 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1008
0143-9768-46Ceftriaxone1 in 1 BOXINJECTION, POWDER, FOR SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9768CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Legacy NDC, 2 package rows20191231_e38c48f6-4d07-422b-9bb2-3c1025946e86.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7

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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLCddbc3bf6-5bab-4851-ae5a-ef263cd8f2552026-07-23Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC86ec0a92-a552-4a6d-9125-a54f95e433922026-06-18Warnings, Adverse reactionsExact identifier
application number: ANDA065328
rxcui: 309090
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC85ce4f8b-77e0-48bf-9f57-93f1478befa22026-04-24Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC9a937e47-8c36-4656-83e1-b3c18ed9bac32026-04-24Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMREMEDYREPACK INC.9c801096-ca61-4b29-a1e1-5f7e7813b1912026-02-06Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMQilu Pharmaceutical Co., Ltd.4cdf0743-c62b-4969-b9c9-4c6400644f6c2026-02-04Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc128bb292-d174-4769-b3e6-9f16617f31e32026-01-22Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc19141ccd-e66c-49a2-a794-0616028495a72026-01-19Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc03283208-8616-4117-9d2b-aa8046017a4f2026-01-19Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc365fc265-8e6c-432f-9fda-911f5f7fb4512026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 309090
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc36c07ebf-b091-483e-b2c4-f0fc0c2b41862026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 309090
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC7bed9b33-29e3-4f04-9766-43a21c7ad47a2026-01-07Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONEWG Critical Care, LLCbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff02025-04-07Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Inc53df951b-2eee-44b1-bae2-df7ed85bc0ed2025-02-28Warnings, Adverse reactionsExact identifier
rxcui: 309090
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Incde028434-46cf-44f6-8ac6-889c7c6943b32025-02-27Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONE SODIUMBaxter Healthcare Company4c5c2d3f-5038-41a1-a2fe-4dcd048dbac12024-10-07Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions53415af6-4072-4339-83e2-d870ae02a0e22024-08-20Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutionsb642877e-0d36-4218-afe9-0a39f35b571d2024-03-27Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
CeftriaxoneCEFTRIAXONECivica, Inc.96f3fc1e-84f4-4e9b-91ac-19a1692f227a2024-02-06Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP790279d4-2456-4091-abec-960b788854322024-02-01Warnings, Adverse reactionsExact identifier
unii: 023Z5BR09K

Reported adverse events (FAERS/openFDA)#

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