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CEFOTAXIME

Prescribing 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.

Approved
Approval ID

a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2010

Manufacturers
FDA

WOCKHARDT LIMITED

DUNS: 650069115

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 Code55648-986
Application NumberANDA065197
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFOTAXIME
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (1)

CEFOTAXIME SODIUMActive
Quantity: 1 g in 1 mL
Code: 258J72S7TZ
Classification: ACTIB

CEFOTAXIME

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55648-947
Application NumberANDA065197
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFOTAXIME
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (1)

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

CEFOTAXIME

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55648-948
Application NumberANDA065197
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFOTAXIME
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (1)

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

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CEFOTAXIME - FDA Drug Approval Details