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Oxacillin

Oxacillin for Injection, USP

Approved
Approval ID

af2dccac-98c8-488f-a133-6374b3ca8dba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 29, 2020

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.

Oxacillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-813
Application NumberANDA206198
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxacillin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 29, 2020
FDA Product Classification

INGREDIENTS (2)

OXACILLIN SODIUMActive
Quantity: 1 g in 20 mL
Code: G0V6C994Q5
Classification: ACTIM
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT

Oxacillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-812
Application NumberANDA206198
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxacillin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 29, 2020
FDA Product Classification

INGREDIENTS (2)

SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
OXACILLIN SODIUMActive
Quantity: 2 g in 20 mL
Code: G0V6C994Q5
Classification: ACTIM

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Oxacillin - FDA Drug Approval Details