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United States · US · US:0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7
Montelukast
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11078155601310 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06)
- ndc11078155603130 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31)
- ndc11078155609290 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A200889
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": {
"52c650cf-3081-7b2c-e063-6394a90a797f": {
"match": "brand_token",
"title": "MONTELUKAST TABLET [REDPHARM DRUG]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7",
"productndc": "0781-5560",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200889",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Aug 3, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MONTELUKAST SODIUM",
"shortage_reason": "Montelukast Sodium Tablet, Chewable",
"shortage_status": "current",
"proprietary_name": "Montelukast",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200889",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast",
"start_marketing_date": "20120803",
"active_numerator_strength": "10"
}Related drugs
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