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CEFAZOLIN

Cefazolin for Injection, USP

Approved
Approval ID

c47c8d14-1eef-40f9-9d11-f0c300b1d4be

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 27, 2023

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 2

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

CEFAZOLIN SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-236
Application NumberANDA065303
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFAZOLIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateSeptember 27, 2023
FDA Product Classification

INGREDIENTS (1)

CEFAZOLIN SODIUMActive
Quantity: 500 mg in 2.2 mL
Code: P380M0454Z
Classification: ACTIM

CEFAZOLIN SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-237
Application NumberANDA065303
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFAZOLIN SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 27, 2023
FDA Product Classification

INGREDIENTS (1)

CEFAZOLIN SODIUMActive
Quantity: 1 g in 3 mL
Code: P380M0454Z
Classification: ACTIM

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CEFAZOLIN - FDA Drug Approval Details