FDA.reportPublic FDA data

Cefotaxime

Product NDC
0143-9931
11-digit product format
001439931
Labeler code
0143
Product ID
0143-9931_7e0897ec-2275-4438-9cc5-4c951e52ad97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefotaxime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065072
Marketing category
ANDA
Marketing start
2002-11-20
Substance
CEFOTAXIME SODIUM
Active strength
1 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefotaxime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOTAXIME SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii258J72S7TZ
Rxcui309068, 1656313, 1656318

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9931-01Cefotaxime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION114
0143-9931-25Cefotaxime25 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9931-01EA - Each0143-99310b508046-3268-4a3f-a17f-2c1337b831e112013-09-04
0143-9931-22EA - Each0143-99317750fa63-6f1e-46f6-8a12-4c354e68043712013-02-11
0143-9931-25EA - Each0143-9931478e1da1-a7b2-47c3-bfb4-9923b42c6bcd12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTAXIME SODIUMACTIVE INGREDIENT258J72S7TZCEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]10
CEFOTAXIMEACTIVE MOIETYN2GI8B1GK7CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9931CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 2 package rows20240413_ed23b6bc-32c7-4c50-a53d-313ae78e5623.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656313cefotaxime 1 GM InjectionPSNed23b6bc-32c7-4c50-a53d-313ae78e562314
1656318cefotaxime 2 GM InjectionPSNed23b6bc-32c7-4c50-a53d-313ae78e562314
309068cefotaxime 500 MG InjectionPSNed23b6bc-32c7-4c50-a53d-313ae78e562314
1656313cefotaxime 1000 MG InjectionSCDed23b6bc-32c7-4c50-a53d-313ae78e562314
1656318cefotaxime 2000 MG InjectionSCDed23b6bc-32c7-4c50-a53d-313ae78e562314
309068cefotaxime 500 MG InjectionSCDed23b6bc-32c7-4c50-a53d-313ae78e562314
1656313cefotaxime (as cefotaxime sodium) 1 GM InjectionSYed23b6bc-32c7-4c50-a53d-313ae78e562314
1656318cefotaxime (as cefotaxime sodium) 2 GM InjectionSYed23b6bc-32c7-4c50-a53d-313ae78e562314
309068cefotaxime (as cefotaxime sodium) 500 MG InjectionSYed23b6bc-32c7-4c50-a53d-313ae78e562314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9931-01001439931011 in 1 VIALHistorical
0143-9931-250014399312525 VIAL in 1 PACKAGE (0143-9931-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01) 25 vial2002-11-200000-00-00NoNoCurrent