NDC 64380-177

ACCOLATE

Zafirlukast

ACCOLATE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Zafirlukast.

• Product ID: 64380-177_bd60d8ba-4d06-49e6-898a-0d05de6078c7
• NDC: 64380-177
• Product Type: Human Prescription Drug
• Proprietary Name: ACCOLATE
• Generic Name: Zafirlukast
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2023-01-02
• Marketing Category: NDA /
• Application Number: NDA020547
• Labeler Name: Strides Pharma Science Limited
• Substance Name: ZAFIRLUKAST
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 64380-177-01

60 TABLET, FILM COATED in 1 BOTTLE (64380-177-01)

• Marketing Start Date: 2023-01-02
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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