zafirlukast

Generic: zafirlukast

Labeler: dr. reddys laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafirlukast
Generic Name zafirlukast
Labeler dr. reddys laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zafirlukast 10 mg/1

Manufacturer
Dr. Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-625
Product ID 55111-625_b5fb9efb-3369-e1f9-384c-bd22e8ecad92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090372
Listing Expiration 2026-12-31
Marketing Start 2010-11-18

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 55111625
Hyphenated Format 55111-625

Supplemental Identifiers

RxCUI
199655 313758
UPC
0355111625605 0355111626602
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 ANDA090372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-625-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-625-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-625-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (55111-625-60)
  • 10 BLISTER PACK in 1 CARTON (55111-625-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79)
source: ndc

Packages (5)

55111-625-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-625-01) 55111-625-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-625-05) 55111-625-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-625-30) 55111-625-60 60 TABLET, FILM COATED in 1 BOTTLE (55111-625-60) 55111-625-78 10 BLISTER PACK in 1 CARTON (55111-625-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79)

Ingredients (1)

zafirlukast (10 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": "b5fb9efb-3369-e1f9-384c-bd22e8ecad92", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "upc": ["0355111625605", "0355111626602"], "unii": ["XZ629S5L50"], "rxcui": ["199655", "313758"], "spl_set_id": ["6ccb96af-2647-9206-5eee-49a825d32488"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-625-01)", "package_ndc": "55111-625-01", "marketing_start_date": "20101118"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-625-05)", "package_ndc": "55111-625-05", "marketing_start_date": "20101118"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-625-30)", "package_ndc": "55111-625-30", "marketing_start_date": "20101118"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (55111-625-60)", "package_ndc": "55111-625-60", "marketing_start_date": "20101118"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-625-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79)", "package_ndc": "55111-625-78", "marketing_start_date": "20101118"}], "brand_name": "Zafirlukast", "product_id": "55111-625_b5fb9efb-3369-e1f9-384c-bd22e8ecad92", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "55111-625", "generic_name": "Zafirlukast", "labeler_name": "Dr. Reddys Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zafirlukast", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "10 mg/1"}], "application_number": "ANDA090372", "marketing_category": "ANDA", "marketing_start_date": "20101118", "listing_expiration_date": "20261231"}