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, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-593
Product ID 55111-593_8bc013e8-5324-099d-e603-d78012b126bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201581
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 55111593
Hyphenated Format 55111-593

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 ANDA201581 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 500 TABLET, CHEWABLE in 1 BOTTLE (55111-593-05)
  • 30 TABLET, CHEWABLE in 1 BOTTLE (55111-593-30)
  • 10 BLISTER PACK in 1 CARTON (55111-593-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-593-79)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (55111-593-90)
source: ndc

Packages (4)

55111-593-05 500 TABLET, CHEWABLE in 1 BOTTLE (55111-593-05) 55111-593-30 30 TABLET, CHEWABLE in 1 BOTTLE (55111-593-30) 55111-593-78 10 BLISTER PACK in 1 CARTON (55111-593-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-593-79) 55111-593-90 90 TABLET, CHEWABLE in 1 BOTTLE (55111-593-90)

Ingredients (1)

montelukast sodium (4 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": "500 TABLET, CHEWABLE in 1 BOTTLE (55111-593-05)", "package_ndc": "55111-593-05", "marketing_start_date": "20120806"}, {"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (55111-593-30)", "package_ndc": "55111-593-30", "marketing_start_date": "20120806"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-593-78)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-593-79)", "package_ndc": "55111-593-78", "marketing_start_date": "20120806"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (55111-593-90)", "package_ndc": "55111-593-90", "marketing_start_date": "20120806"}], "brand_name": "Montelukast Sodium", "product_id": "55111-593_8bc013e8-5324-099d-e603-d78012b126bd", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "55111-593", "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": "4 mg/1"}], "application_number": "ANDA201581", "marketing_category": "ANDA", "marketing_start_date": "20120806", "listing_expiration_date": "20261231"}