NDC 10122-901

ZYFLO

Zileuton

ZYFLO is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Zileuton.

• Product ID: 10122-901_2ca0eba1-1472-455f-95d2-d96cf271565e
• NDC: 10122-901
• Product Type: Human Prescription Drug
• Proprietary Name: ZYFLO
• Generic Name: Zileuton
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1996-12-06
• Marketing Category: NDA / NDA
• Application Number: NDA020471
• Labeler Name: Chiesi USA, Inc.
• Substance Name: ZILEUTON
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: 5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10122-901-12

120 TABLET in 1 BOTTLE (10122-901-12)

• Marketing Start Date: 1996-12-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10122-901-12 [10122090112]

ZYFLO TABLET

• Marketing Category: NDA
• Application Number: NDA020471
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-12-06

NDC 10122-901-10 [10122090110]

ZYFLO TABLET

• Marketing Category: NDA
• Application Number: NDA020471
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-06
• Marketing End Date: 2011-07-12

Drug Details

Active Ingredients

Ingredient	Strength
ZILEUTON	600 mg/1

OpenFDA Data

• SPL SET ID: aee65202-fddb-497f-9f11-17cc727cb157
• Manufacturer:
  • Chiesi USA, Inc.
• UNII:
  • V1L22WVE2S
• RxNorm Concept Unique ID - RxCUI:
  • 211777
  • 199904

Pharmacological Class

• 5-Lipoxygenase Inhibitors [MoA]
• Decreased Leukotriene Production [PE]
• 5-Lipoxygenase Inhibitor [EPC]

NDC Crossover Matching brand name "ZYFLO" or generic name "Zileuton"

NDC	Brand Name	Generic Name
10122-901	ZYFLO	zileuton
31722-044	Zileuton	Zileuton
49884-723	Zileuton	zileuton
64380-189	Zileuton	zileuton
64980-206	Zileuton	Zileuton
66993-485	Zileuton	Zileuton
68180-169	ZILEUTON	Zileuton
69339-130	Zileuton	zileuton
10122-902	ZYFLO CR	zileuton