NDC 10122-902

ZYFLO CR

Zileuton

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

• Product ID: 10122-902_66955d15-d2e7-4513-abb1-dfb8c8aae090
• NDC: 10122-902
• Product Type: Human Prescription Drug
• Proprietary Name: ZYFLO CR
• Generic Name: Zileuton
• Dosage Form: Tablet, Multilayer, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2007-05-30
• Marketing Category: NDA / NDA
• Application Number: NDA022052
• 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: 2020-12-31

Packaging

NDC 10122-902-12

120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-12)

• Marketing Start Date: 2007-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10122-902-12 [10122090212]

ZYFLO CR TABLET, MULTILAYER, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022052
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-05-30
• Marketing End Date: 2019-12-31

NDC 10122-902-20 [10122090220]

ZYFLO CR TABLET, MULTILAYER, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022052
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-05-30
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ZILEUTON	600 mg/1

OpenFDA Data

• SPL SET ID: 9bc08d7b-13da-444f-ac8a-3714a05176cc
• Manufacturer:
  • Chiesi USA, Inc.
• UNII:
  • V1L22WVE2S
• RxNorm Concept Unique ID - RxCUI:
  • 730834
  • 790889

Pharmacological Class

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

Medicade Reported Pricing

10122090212 ZYFLO CR 600 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
10122-902	ZYFLO CR	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
10122-901	ZYFLO	zileuton