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NAFCILLIN SODIUM

Nafcillin for Injection, USP For Intramuscular or Intravenous Injection

Approved
Approval ID

344455bd-051d-4c4a-b76e-8c4dd9351d97

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 17, 2023

Manufacturers
FDA

Steriscience Specialties Private Limited

DUNS: 853179150

Products 2

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

NAFCILLIN SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82449-503
Application NumberANDA200002
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAFCILLIN SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 17, 2023
FDA Product Classification

INGREDIENTS (2)

NAFCILLIN SODIUMActive
Quantity: 1 g in 1 1
Code: 49G3001BCK
Classification: ACTIM
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

NAFCILLIN SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82449-504
Application NumberANDA200002
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAFCILLIN SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 17, 2023
FDA Product Classification

INGREDIENTS (2)

SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
NAFCILLIN SODIUMActive
Quantity: 2 g in 1 1
Code: 49G3001BCK
Classification: ACTIM

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NAFCILLIN SODIUM - FDA Drug Approval Details