montelukast sodium

Generic: montelukast sodium

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-781
Product ID 63187-781_e36b33e0-a969-46fc-8a6a-c62f4ae61607
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202717
Listing Expiration 2026-12-31
Marketing Start 2013-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187781
Hyphenated Format 63187-781

Supplemental Identifiers

RxCUI
200224
UPC
0363187781903
UNII
U1O3J18SFL

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 ANDA202717 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE (63187-781-14)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-781-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-781-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-781-90)
source: ndc

Packages (4)

63187-781-14 14 TABLET, FILM COATED in 1 BOTTLE (63187-781-14) 63187-781-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-781-30) 63187-781-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-781-60) 63187-781-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-781-90)

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": "e36b33e0-a969-46fc-8a6a-c62f4ae61607", "openfda": {"upc": ["0363187781903"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (63187-781-14)", "package_ndc": "63187-781-14", "marketing_start_date": "20180904"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-781-30)", "package_ndc": "63187-781-30", "marketing_start_date": "20161101"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-781-60)", "package_ndc": "63187-781-60", "marketing_start_date": "20161101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-781-90)", "package_ndc": "63187-781-90", "marketing_start_date": "20161101"}], "brand_name": "Montelukast Sodium", "product_id": "63187-781_e36b33e0-a969-46fc-8a6a-c62f4ae61607", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "63187-781", "generic_name": "Montelukast Sodium", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202717", "marketing_category": "ANDA", "marketing_start_date": "20130411", "listing_expiration_date": "20261231"}