🇺🇸
United States · US · US:63187-692_51ba5811-a7f6-4c07-abde-873a75ba5554
MONTELUKAST SODIUM
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631876923030 TABLET, COATED in 1 BOTTLE (63187-692-30)
- ndc11631876926060 TABLET, COATED in 1 BOTTLE (63187-692-60)
- ndc11631876929090 TABLET, COATED in 1 BOTTLE (63187-692-90)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A203432
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": "63187-692_51ba5811-a7f6-4c07-abde-873a75ba5554",
"productndc": "63187-692",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "203432",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jul 31, 2015"
}
],
"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 SODIUM",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203432",
"marketing_category": "ANDA",
"nonproprietary_name": "MONTELUKAST SODIUM",
"start_marketing_date": "20151110",
"active_numerator_strength": "10"
}Related drugs
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Access this data programmatically
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