NDC 66298-5137

Zyvox

Linezolid

Zyvox is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Norge As. The primary component is Linezolid.

• Product ID: 66298-5137_74f6ba39-459c-c32b-e053-2991aa0a665c
• NDC: 66298-5137
• Product Type: Human Prescription Drug
• Proprietary Name: Zyvox
• Generic Name: Linezolid
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-06-04
• Marketing Category: NDA / NDA
• Application Number: NDA021131
• Labeler Name: Fresenius Kabi Norge As
• Substance Name: LINEZOLID
• Active Ingredient Strength: 200 mg/100mL
• Pharm Classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 66298-5137-1

100 mL in 1 BAG (66298-5137-1)

• Marketing Start Date: 2018-06-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66298-5137-1 [66298513701]

Zyvox INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021131
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-04

Drug Details

Active Ingredients

Ingredient	Strength
LINEZOLID	200 mg/100mL

OpenFDA Data

• SPL SET ID: ce57225b-4580-442b-8c48-8045297cbb50
• Manufacturer:
  • Fresenius Kabi Norge As
• UNII:
  • ISQ9I6J12J
• RxNorm Concept Unique ID - RxCUI:
  • 1662278
  • 1662280

Pharmacological Class

• Oxazolidinone Antibacterial [EPC]
• Oxazolidinones [CS]
• 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