Last Updated: May 10, 2026

Details for New Drug Application (NDA): 090005

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NDA 090005 describes NAFCILLIN SODIUM, which is a drug marketed by Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Onesource Specialty, Sagent Pharms, Sandoz, and Watson Labs Inc, and is included in fifteen NDAs. It is available from ten suppliers. Additional details are available on the NAFCILLIN SODIUM profile page.

The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for 090005

Tradename:	NAFCILLIN SODIUM
Applicant:	Istituto Bio Ita Spa
Ingredient:	nafcillin sodium
Patents:	0

Pharmacology for NDA: 090005

Medical Subject Heading (MeSH) Categories for 090005

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 090005

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090005	ANDA	Sagent Pharmaceuticals	25021-198	25021-198-99	1 VIAL in 1 CARTON (25021-198-99) / 100 mL in 1 VIAL
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090005	ANDA	WG Critical Care, LLC	44567-223	44567-223-01	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-223-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Apr 20, 2011	TE:	AP	RLD:	No

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