MedPath

Cefotaxime

CEFOTAXIME FOR INJECTION, USP

Approved
Approval ID

ed23b6bc-32c7-4c50-a53d-313ae78e5623

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 25, 2021

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cefotaxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9930
Application NumberANDA065072
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotaxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 25, 2021
FDA Product Classification

INGREDIENTS (1)

CEFOTAXIME SODIUMActive
Quantity: 500 mg in 1 1
Code: 258J72S7TZ
Classification: ACTIM

Cefotaxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9931
Application NumberANDA065072
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotaxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 25, 2021
FDA Product Classification

INGREDIENTS (1)

CEFOTAXIME SODIUMActive
Quantity: 1 g in 1 1
Code: 258J72S7TZ
Classification: ACTIM

Cefotaxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9933
Application NumberANDA065072
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotaxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 25, 2021
FDA Product Classification

INGREDIENTS (1)

CEFOTAXIME SODIUMActive
Quantity: 2 g in 1 1
Code: 258J72S7TZ
Classification: ACTIM

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