NDC 0009-5138

Zyvox

Linezolid

Zyvox is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmacia & Upjohn Company Llc. The primary component is Linezolid.

• Product ID: 0009-5138_1be6b985-dd41-4264-9c2f-93d52db3641e
• NDC: 0009-5138
• Product Type: Human Prescription Drug
• Proprietary Name: Zyvox
• Generic Name: Linezolid
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-12
• Marketing Category: NDA / NDA
• Application Number: NDA021130
• Labeler Name: Pharmacia & Upjohn Company LLC
• Substance Name: LINEZOLID
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0009-5138-02

20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02)

• Marketing Start Date: 2015-10-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-5138-03 [00009513803]

Zyvox TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021130
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-12

NDC 0009-5138-02 [00009513802]

Zyvox TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021130
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-12

Drug Details

Active Ingredients

Ingredient	Strength
LINEZOLID	600 mg/1

OpenFDA Data

• SPL SET ID: 6e70e63b-bfd5-478d-a8ee-8ba22c9efabd
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • ISQ9I6J12J
• RxNorm Concept Unique ID - RxCUI:
  • 1662285
  • 1662286
  • 1662278
  • 1662280
  • 581614
  • 311347
  • 262091
  • 311345
• UPC Code:
  • 0300095135022
  • 0300095138023

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