NDC 70518-1226

Zyvox

Linezolid

Zyvox is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Linezolid.

• Product ID: 70518-1226_9af83d8c-79c0-1321-e053-2a95a90acb30
• NDC: 70518-1226
• Product Type: Human Prescription Drug
• Proprietary Name: Zyvox
• Generic Name: Linezolid
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-08
• Marketing Category: NDA / NDA
• Application Number: NDA021130
• Labeler Name: REMEDYREPACK INC.
• Substance Name: LINEZOLID
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-1226-1

20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1226-1)

• Marketing Start Date: 2019-12-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1226-0 [70518122600]

Zyvox TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021130
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-08

NDC 70518-1226-1 [70518122601]

Zyvox TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021130
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-24

Drug Details

Active Ingredients

Ingredient	Strength
LINEZOLID	600 mg/1

OpenFDA Data

• SPL SET ID: 57a5e8e4-7f01-4786-bfc5-4656c7dca249
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • ISQ9I6J12J
• RxNorm Concept Unique ID - RxCUI:
  • 311347
  • 262091

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