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United States · US · US:78206-172_57a12189-3bb3-4a5d-b5fe-fc57db87c134
SINGULAIR
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOrganon LLC
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11782061720130 TABLET, FILM COATED in 1 BOTTLE (78206-172-01)
- ndc11782061720290 TABLET, FILM COATED in 1 BOTTLE (78206-172-02)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
N020829
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Montelukast Sodium Tablet, Chewable
Raw payload (JSON)
{
"unii": {
"unii": "U1O3J18SFL",
"rxcui": "115713",
"inchikey": "LBFBRXGCXUHRJY-HKHDRNBDSA-M",
"display_name": "MONTELUKAST SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"482dcc92-b47f-4ea6-854a-f5ac2aea7842": {
"match": "brand_token",
"title": "SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [ORGANON LLC]",
"spl_version": "5",
"published_date": "2025-06-25"
}
},
"productid": "78206-172_57a12189-3bb3-4a5d-b5fe-fc57db87c134",
"productndc": "78206-172",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020829",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Feb 20, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MONTELUKAST SODIUM",
"shortage_reason": "Montelukast Sodium Tablet, Chewable",
"shortage_status": "current",
"proprietary_name": "SINGULAIR",
"active_ingred_unit": "mg/1",
"application_number": "NDA020829",
"marketing_category": "NDA",
"nonproprietary_name": "montelukast sodium",
"start_marketing_date": "20210601",
"active_numerator_strength": "10"
}Related drugs
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