NDC 49884-589

Accolate

Zafirlukast

Accolate is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Zafirlukast.

• Product ID: 49884-589_07d08882-dbc5-48f4-a5d8-96ebf858bf92
• NDC: 49884-589
• Product Type: Human Prescription Drug
• Proprietary Name: Accolate
• Generic Name: Zafirlukast
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA020547
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: ZAFIRLUKAST
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49884-589-02

60 TABLET, COATED in 1 BOTTLE (49884-589-02)

• Marketing Start Date: 2015-11-01
• Marketing End Date: 2024-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49884-589-02 [49884058902]

Accolate TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA020547
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-01

Drug Details

Active Ingredients

Ingredient	Strength
ZAFIRLUKAST	10 mg/1

OpenFDA Data

• SPL SET ID: d31ecca3-23ff-470e-8c91-1bea8a537b3c
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • XZ629S5L50
• RxNorm Concept Unique ID - RxCUI:
  • 211776
  • 313758
  • 261313
  • 199655
• UPC Code:
  • 0349884123451

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