singulair

Generic: montelukast sodium

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name singulair
Generic Name montelukast sodium
Labeler organon llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-172
Product ID 78206-172_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020829
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206172
Hyphenated Format 78206-172

Supplemental Identifiers

RxCUI
153892 153893 200224 242438 261367 311759 351246 404406
UPC
0378206173010 0378206170019
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 singulair (source: ndc)
Generic Name montelukast sodium (source: ndc)
Application Number NDA020829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (78206-172-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (78206-172-02)
source: ndc

Packages (2)

78206-172-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-172-01) 78206-172-02 90 TABLET, FILM COATED in 1 BOTTLE (78206-172-02)

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

SINGULAIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "57a12189-3bb3-4a5d-b5fe-fc57db87c134", "openfda": {"upc": ["0378206173010", "0378206170019"], "unii": ["U1O3J18SFL"], "rxcui": ["153892", "153893", "200224", "242438", "261367", "311759", "351246", "404406"], "spl_set_id": ["482dcc92-b47f-4ea6-854a-f5ac2aea7842"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (78206-172-01)", "package_ndc": "78206-172-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (78206-172-02)", "package_ndc": "78206-172-02", "marketing_start_date": "20210601"}], "brand_name": "SINGULAIR", "product_id": "78206-172_57a12189-3bb3-4a5d-b5fe-fc57db87c134", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "78206-172", "generic_name": "montelukast sodium", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SINGULAIR", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "NDA020829", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}