FDA.reportPublic FDA data

Cefotaxime

Product NDC
64679-947
11-digit product format
646790947
Labeler code
64679
Product ID
64679-947_4d51bfa3-dadf-44bc-a2b6-75f477945341
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefotaxime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wockhardt USA LLC.
Application
ANDA065197
Marketing category
ANDA
Marketing start
2008-06-20
Marketing end
0000-00-00
Substance
CEFOTAXIME SODIUM
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
64679-947-012021-01-29C16284748780-1ba0f9c33-2bba-a910-e053-dadaa90a0b85Prescribing information Cefotaxime for Injection, USP 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.
64679-947-022021-01-29C16284748780-1ba0f9c33-2bba-a910-e053-dadaa90a0b85Prescribing information Cefotaxime for Injection, USP 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
64679-947-01Cefotaxime1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
64679-947-02Cefotaxime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104
64679-947-02Cefotaxime1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTAXIME SODIUMACTIVE INGREDIENT258J72S7TZCEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT USA LLC.]1
CEFOTAXIMEACTIVE MOIETYN2GI8B1GK7CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT USA LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-947CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT USA LLC.]4Legacy NDC, 3 package rows20200125_f3c5895f-f54b-43d4-9b38-7bfbdf8335b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656313cefotaxime 1 GM InjectionPSNf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
1656318cefotaxime 2 GM InjectionPSNf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
309068cefotaxime 500 MG InjectionPSNf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
1656313cefotaxime 1000 MG InjectionSCDf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
1656318cefotaxime 2000 MG InjectionSCDf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
309068cefotaxime 500 MG InjectionSCDf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
1656313cefotaxime (as cefotaxime sodium) 1 GM InjectionSYf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
1656318cefotaxime (as cefotaxime sodium) 2 GM InjectionSYf3c5895f-f54b-43d4-9b38-7bfbdf8335b74
309068cefotaxime (as cefotaxime sodium) 500 MG InjectionSYf3c5895f-f54b-43d4-9b38-7bfbdf8335b74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64679-947-01646790947011 in 1 CARTONHistorical
64679-947-026467909470210 in 1 CARTONHistorical