FDA.reportPublic FDA data

CEFOTAXIME

Product NDC
55648-986
11-digit product format
556480986
Labeler code
55648
Product ID
55648-986_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFOTAXIME
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WOCKHARDT LIMITED
Application
ANDA065197
Marketing category
ANDA
Marketing start
2006-08-29
Marketing end
0000-00-00
Substance
CEFOTAXIME SODIUM
Active strength
1 g/mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
240c5dde-7ad4-44da-afce-de9486640146Product name220160328

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-986-022019-10-29C16284748780-1960f7f55-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.
55648-986-032019-10-29C16284748780-1960f7f55-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.
55648-986-042019-10-29C16284748780-1960f7f55-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
55648-986-01CEFOTAXIME1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
55648-986-01CEFOTAXIME10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION101
55648-986-02CEFOTAXIME10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101
55648-986-03CEFOTAXIME25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION251
55648-986-04CEFOTAXIME50 in 1 CARTONINJECTION, POWDER, FOR SOLUTION501

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-986CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20101026_a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656313cefotaxime 1 GM InjectionPSNa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656318cefotaxime 2 GM InjectionPSNa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
309068cefotaxime 500 MG InjectionPSNa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656313cefotaxime 1000 MG InjectionSCDa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656318cefotaxime 2000 MG InjectionSCDa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
309068cefotaxime 500 MG InjectionSCDa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656313cefotaxime (as cefotaxime sodium) 1 GM InjectionSYa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656318cefotaxime (as cefotaxime sodium) 2 GM InjectionSYa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
309068cefotaxime (as cefotaxime sodium) 500 MG InjectionSYa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-986-01556480986011 in 1 CARTONHistorical
55648-986-025564809860210 in 1 CARTONHistorical
55648-986-035564809860325 in 1 CARTONHistorical
55648-986-045564809860450 in 1 CARTONHistorical