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United States · US · US:72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1
Montelukast
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1172865175101000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10)
- ndc11728651753030 TABLET, FILM COATED in 1 BOTTLE (72865-175-30)
- ndc11728651759090 TABLET, FILM COATED in 1 BOTTLE (72865-175-90)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A202843
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": "72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1",
"productndc": "72865-175",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202843",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Sep 10, 2014"
}
],
"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": "ANDA202843",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast",
"start_marketing_date": "20210211",
"active_numerator_strength": "10"
}Related drugs
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