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Cefuroxime

CEFUROXIME FOR INJECTION, USP

Approved
Approval ID

19902965-d2d6-433f-982d-0095014df4e8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 27, 2018

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 Code0143-9568
Application NumberANDA065048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 27, 2018
FDA Product Classification

INGREDIENTS (1)

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

Cefuroxime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9567
Application NumberANDA065048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2018
FDA Product Classification

INGREDIENTS (1)

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

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