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Nafcillin

Nafcillin for Injection, USP

Approved
Approval ID

c39721a3-7b22-4720-9dbd-bc82f03d2af7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 17, 2019

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.

NAFCILLIN SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-327
Application NumberANDA090002
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAFCILLIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 17, 2019
FDA Product Classification

INGREDIENTS (2)

SODIUM CITRATEInactive
Quantity: 40 mg in 4 mL
Code: 1Q73Q2JULR
Classification: IACT
NAFCILLIN SODIUMActive
Quantity: 1 g in 4 mL
Code: 49G3001BCK
Classification: ACTIM

NAFCILLIN SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-328
Application NumberANDA090002
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAFCILLIN SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 17, 2019
FDA Product Classification

INGREDIENTS (2)

SODIUM CITRATEInactive
Quantity: 40 mg in 8 mL
Code: 1Q73Q2JULR
Classification: IACT
NAFCILLIN SODIUMActive
Quantity: 2 g in 8 mL
Code: 49G3001BCK
Classification: ACTIM

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Nafcillin - FDA Drug Approval Details