zafirlukast

Generic: zafirlukast

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafirlukast
Generic Name zafirlukast
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zafirlukast 20 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-008
Product ID 31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212475
Listing Expiration 2026-12-31
Marketing Start 2020-09-10

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 31722008
Hyphenated Format 31722-008

Supplemental Identifiers

RxCUI
199655 313758
UPC
0331722007603 0331722008600
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 zafirlukast (source: ndc)
Generic Name zafirlukast (source: ndc)
Application Number ANDA212475 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (31722-008-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-008-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-008-60)
source: ndc

Packages (3)

31722-008-01 10 BLISTER PACK in 1 CARTON (31722-008-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK 31722-008-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-008-05) 31722-008-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-008-60)

Ingredients (1)

zafirlukast (20 mg/1)

Linked Drug Pages (1)

Zafirlukast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5d30ffab-38a1-411d-94ad-0a15c227d882", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "upc": ["0331722007603", "0331722008600"], "unii": ["XZ629S5L50"], "rxcui": ["199655", "313758"], "spl_set_id": ["5d30ffab-38a1-411d-94ad-0a15c227d882"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-008-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "31722-008-01", "marketing_start_date": "20200910"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-008-05)", "package_ndc": "31722-008-05", "marketing_start_date": "20200910"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-008-60)", "package_ndc": "31722-008-60", "marketing_start_date": "20200910"}], "brand_name": "Zafirlukast", "product_id": "31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "31722-008", "generic_name": "Zafirlukast", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zafirlukast", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "20 mg/1"}], "application_number": "ANDA212475", "marketing_category": "ANDA", "marketing_start_date": "20200910", "listing_expiration_date": "20261231"}