NDC 53808-0203

ACCOLATE

Zafirlukast

ACCOLATE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Zafirlukast.

• Product ID: 53808-0203_9798152d-b3b5-4fc6-985e-10b59177464b
• NDC: 53808-0203
• Product Type: Human Prescription Drug
• Proprietary Name: ACCOLATE
• Generic Name: Zafirlukast
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA020547
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: ZAFIRLUKAST
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53808-0203-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0203-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0203-1 [53808020301]

ACCOLATE TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020547
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
ZAFIRLUKAST	20 mg/1

OpenFDA Data

• SPL SET ID: 4bf90772-58d5-456d-ad1c-fc448cc5a231
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • XZ629S5L50
• RxNorm Concept Unique ID - RxCUI:
  • 211776
  • 199655

Pharmacological Class

• Leukotriene Receptor Antagonists [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]
• Leukotriene Receptor Antagonist [EPC]

NDC Crossover Matching brand name "ACCOLATE" or generic name "Zafirlukast"

NDC	Brand Name	Generic Name
49884-010	ACCOLATE	zafirlukast
49884-011	ACCOLATE	zafirlukast
49884-589	Accolate	zafirlukast
49884-590	Accolate	zafirlukast
53808-0203	ACCOLATE	Zafirlukast
64380-177	ACCOLATE	Zafirlukast
64380-178	ACCOLATE	Zafirlukast
0904-6646	Zafirlukast	zafirlukast
16571-654	Zafirlukast	Zafirlukast
31722-007	Zafirlukast	Zafirlukast
31722-008	Zafirlukast	Zafirlukast
49884-549	Zafirlukast	zafirlukast
49884-554	Zafirlukast	zafirlukast
50268-805	Zafirlukast	Zafirlukast
55111-625	Zafirlukast	Zafirlukast
55111-626	Zafirlukast	Zafirlukast
63629-2102	Zafirlukast	zafirlukast
64380-187	Zafirlukast	zafirlukast
64380-188	Zafirlukast	zafirlukast
68084-059	Zafirlukast	Zafirlukast
68151-1977	Zafirlukast	Zafirlukast