🇺🇸
United States · US · US:63187-430_3987b125-2cd5-4cae-9009-4e839599a38e
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
- ndc11631874303030 TABLET in 1 BOTTLE (63187-430-30)
- ndc11631874306060 TABLET in 1 BOTTLE (63187-430-60)
- ndc11631874309090 TABLET in 1 BOTTLE (63187-430-90)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A201515
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": "63187-430_3987b125-2cd5-4cae-9009-4e839599a38e",
"productndc": "63187-430",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "201515",
"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 Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201515",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast Sodium",
"start_marketing_date": "20120803",
"active_numerator_strength": "10"
}Related drugs
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