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Cefotaxime

Prescribing 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.

Approved
Approval ID

f3c5895f-f54b-43d4-9b38-7bfbdf8335b7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 26, 2019

Manufacturers
FDA

Wockhardt USA LLC.

DUNS: 170508365

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 Code64679-948
Application NumberANDA065197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotaxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 26, 2019
FDA Product Classification

INGREDIENTS (1)

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

Cefotaxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64679-986
Application NumberANDA065197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotaxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 26, 2019
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 Code64679-947
Application NumberANDA065197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotaxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 26, 2019
FDA Product Classification

INGREDIENTS (1)

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

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