FDA.reportPublic FDA data

NDC 55648-948-01 - CEFOTAXIME

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
55648-948
Requested NDC
55648-948-01
Package NDCs from labels
55648-948-01, 55648-948-02
Manufacturer
WOCKHARDT LIMITED
Effective date
2010-10-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CEFOTAXIME - WOCKHARDT LIMITEDWOCKHARDT LIMITED2010-10-19HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-948-022019-10-29C16284748780-1960f7f55-d1d5-8e05-e053-dbdaa90a074aPrescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-948-01CEFOTAXIME1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
55648-948-01CEFOTAXIME20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION201
55648-948-02CEFOTAXIME10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-948CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]1Legacy NDC, 3 package rows20101026_a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTAXIME SODIUMACTIVE INGREDIENT258J72S7TZCEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]1
CEFOTAXIMEACTIVE MOIETYN2GI8B1GK7CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]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 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefotaximeCEFOTAXIME INJECTIONSteriMax Inc.8efe3bd0-c43a-2bd6-e053-2a95a90a92fa2026-06-15Exact identifier
rxcui: 1656313
rxcui: 1656318
unii: 258J72S7TZ
CefotaximeCEFOTAXIMEHikma Pharmaceuticals USA Inc.ed23b6bc-32c7-4c50-a53d-313ae78e56232024-04-11Warnings, Adverse reactionsExact identifier
rxcui: 309068
rxcui: 1656313
rxcui: 1656318
unii: 258J72S7TZ
CefotaximeCEFOTAXIMEHikma Pharmaceuticals USA Inc.ef1a6dc6-bc3d-4f09-8f92-7ff328f565612024-04-11Warnings, Adverse reactionsExact identifier
unii: 258J72S7TZ
ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5ba401a44e-2c5c-4c4a-81d8-56a3ef9d57f72010-10-19Warnings, Adverse reactionsExact identifier
spl id: ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b
spl set id: a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7

Reported adverse events (FAERS/openFDA)#

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