🇺🇸
United States · US · US:65162-732_ce5720a0-a4c1-4532-8112-53201502c0eb
Montelukast Sodium
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651627320330 TABLET in 1 BOTTLE (65162-732-03)
- ndc11651627320990 TABLET in 1 BOTTLE (65162-732-09)
- ndc1165162732111000 TABLET in 1 BOTTLE (65162-732-11)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A204604
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": "65162-732_ce5720a0-a4c1-4532-8112-53201502c0eb",
"productndc": "65162-732",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204604",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Sep 4, 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": "ANDA204604",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast",
"start_marketing_date": "20130731",
"active_numerator_strength": "10"
}Related drugs
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