accolate

Generic: zafirlukast

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name accolate
Generic Name zafirlukast
Labeler strides pharma science limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zafirlukast 20 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-178
Product ID 64380-178_b73fd0be-3cb6-4284-817b-a4fec41a3a6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020547
Listing Expiration 2026-12-31
Marketing Start 2023-01-02

Pharmacologic Class

Established (EPC)
leukotriene receptor antagonist [epc]
Mechanism of Action
leukotriene receptor antagonists [moa] cytochrome p450 2c9 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380178
Hyphenated Format 64380-178

Supplemental Identifiers

RxCUI
199655 211776 261313 313758
UNII
XZ629S5L50
NUI
N0000175777 N0000000083 N0000185504

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name accolate (source: ndc)
Generic Name zafirlukast (source: ndc)
Application Number NDA020547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (64380-178-01)
source: ndc

Packages (1)

64380-178-01 60 TABLET, FILM COATED in 1 BOTTLE (64380-178-01)

Ingredients (1)

zafirlukast (20 mg/1)

Linked Drug Pages (1)

ACCOLATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b73fd0be-3cb6-4284-817b-a4fec41a3a6a", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "unii": ["XZ629S5L50"], "rxcui": ["199655", "211776", "261313", "313758"], "spl_set_id": ["3bbd0e85-6014-46cd-a363-60102c4bc5a2"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (64380-178-01)", "package_ndc": "64380-178-01", "marketing_start_date": "20230102"}], "brand_name": "ACCOLATE", "product_id": "64380-178_b73fd0be-3cb6-4284-817b-a4fec41a3a6a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "64380-178", "generic_name": "Zafirlukast", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACCOLATE", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "20 mg/1"}], "application_number": "NDA020547", "marketing_category": "NDA", "marketing_start_date": "20230102", "listing_expiration_date": "20261231"}