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Cefuroxime

CEFUROXIME FOR INJECTION, USP

Approved
Approval ID

703cc338-c0b6-4a02-b8db-c27aeff181df

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 8, 2020

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

Products 2

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

Cefuroxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9977
Application NumberANDA065048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 8, 2020
FDA Product Classification

INGREDIENTS (1)

CEFUROXIME SODIUMActive
Quantity: 1.5 g in 1 1
Code: R8A7M9MY61
Classification: ACTIM

Cefuroxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9979
Application NumberANDA065048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 8, 2020
FDA Product Classification

INGREDIENTS (1)

CEFUROXIME SODIUMActive
Quantity: 750 mg in 1 1
Code: R8A7M9MY61
Classification: ACTIM

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Cefuroxime - FDA Drug Approval Details