montelukast sodium

Generic: montelukast sodium

Labeler: dr.reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler dr.reddy's laboratories limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-725
Product ID 55111-725_8bc013e8-5324-099d-e603-d78012b126bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201582
Listing Expiration 2026-12-31
Marketing Start 2012-08-06

Pharmacologic Class

Classes
leukotriene receptor antagonist [epc] leukotriene receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111725
Hyphenated Format 55111-725

Supplemental Identifiers

RxCUI
200224 242438 311759
UNII
U1O3J18SFL

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 montelukast sodium (source: ndc)
Generic Name montelukast sodium (source: ndc)
Application Number ANDA201582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (55111-725-01)
  • 1000 TABLET, COATED in 1 BOTTLE (55111-725-10)
  • 30 TABLET, COATED in 1 BOTTLE (55111-725-30)
  • 10 BLISTER PACK in 1 CARTON (55111-725-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-725-79)
  • 90 TABLET, COATED in 1 BOTTLE (55111-725-90)
source: ndc

Packages (5)

55111-725-01 100 TABLET, COATED in 1 BOTTLE (55111-725-01) 55111-725-10 1000 TABLET, COATED in 1 BOTTLE (55111-725-10) 55111-725-30 30 TABLET, COATED in 1 BOTTLE (55111-725-30) 55111-725-78 10 BLISTER PACK in 1 CARTON (55111-725-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-725-79) 55111-725-90 90 TABLET, COATED in 1 BOTTLE (55111-725-90)

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

Montelukast Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8bc013e8-5324-099d-e603-d78012b126bd", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759"], "spl_set_id": ["3d4451a9-d73d-b9de-68ec-853bfeff6e4b"], "manufacturer_name": ["Dr.Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (55111-725-01)", "package_ndc": "55111-725-01", "marketing_start_date": "20120806"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (55111-725-10)", "package_ndc": "55111-725-10", "marketing_start_date": "20120806"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (55111-725-30)", "package_ndc": "55111-725-30", "marketing_start_date": "20120806"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-725-78)  / 10 TABLET, COATED in 1 BLISTER PACK (55111-725-79)", "package_ndc": "55111-725-78", "marketing_start_date": "20120806"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (55111-725-90)", "package_ndc": "55111-725-90", "marketing_start_date": "20120806"}], "brand_name": "Montelukast Sodium", "product_id": "55111-725_8bc013e8-5324-099d-e603-d78012b126bd", "dosage_form": "TABLET, COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "55111-725", "generic_name": "Montelukast Sodium", "labeler_name": "Dr.Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA201582", "marketing_category": "ANDA", "marketing_start_date": "20120806", "listing_expiration_date": "20261231"}