NDC 0009-4992

Zyvox

Linezolid

Zyvox is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Linezolid.

• Product ID: 0009-4992_34a504b9-0cea-4852-be26-141cde457f85
• NDC: 0009-4992
• Product Type: Human Prescription Drug
• Proprietary Name: Zyvox
• Generic Name: Linezolid
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-07-06
• Marketing Category: NDA / NDA
• Application Number: NDA021131
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: LINEZOLID
• Active Ingredient Strength: 600 mg/300mL
• Pharm Classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0009-4992-02

10 BAG in 1 BOX (0009-4992-02) > 300 mL in 1 BAG (0009-4992-01)

• Marketing Start Date: 2015-07-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-4992-02 [00009499202]

Zyvox INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021131
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-06

NDC 0009-4992-01 [00009499201]

Zyvox INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021131
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-06

Drug Details

Active Ingredients

Ingredient	Strength
LINEZOLID	600 mg/300mL

OpenFDA Data

• SPL SET ID: 122faa9e-c71a-4597-9552-5fb330b7d8b9
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • ISQ9I6J12J
• RxNorm Concept Unique ID - RxCUI:
  • 1662286
  • 1662285

Pharmacological Class

• Oxazolidinone Antibacterial [EPC]
• Oxazolidinones [CS]

NDC Crossover Matching brand name "Zyvox" or generic name "Linezolid"

NDC	Brand Name	Generic Name
0009-4992	Zyvox	linezolid
0009-5136	Zyvox	linezolid
0009-5137	Zyvox	linezolid
0009-5138	Zyvox	linezolid
0009-5140	Zyvox	linezolid
21695-399	Zyvox	Zyvox
0009-7807	Zyvox	Zyvox
55695-009	Zyvox	Zyvox
66298-5137	Zyvox	Zyvox
66298-5140	Zyvox	Zyvox
66298-4992	Zyvox	Zyvox
66298-7807	Zyvox	Zyvox
70518-1226	Zyvox	Zyvox