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 GRANULE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-171
Product ID 78206-171_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021409
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 78206171
Hyphenated Format 78206-171

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 NDA021409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET
source: ndc

Packages (1)

78206-171-01 30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET

Ingredients (1)

montelukast sodium (4 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 PACKET in 1 CARTON (78206-171-01)  / 1 GRANULE in 1 PACKET", "package_ndc": "78206-171-01", "marketing_start_date": "20210601"}], "brand_name": "SINGULAIR", "product_id": "78206-171_57a12189-3bb3-4a5d-b5fe-fc57db87c134", "dosage_form": "GRANULE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "78206-171", "generic_name": "montelukast sodium", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SINGULAIR", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/1"}], "application_number": "NDA021409", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}