🇺🇸
United States · US · US:65162-771_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c
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 · 1
- ndc11651627710330 TABLET, CHEWABLE in 1 BOTTLE (65162-771-03)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A205107
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": "65162-771_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c",
"productndc": "65162-771",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "205107",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "001",
"approval_date": "Sep 4, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Sep 4, 2020"
}
],
"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": "ANDA205107",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast",
"start_marketing_date": "20200904",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code R03DC53.
- 🇮🇹ALEAST*28 cpr mast 4 mgLANOVA FARMACEUTICI Srl
- 🇮🇹ALEAST*28 cpr mast 5 mgLANOVA FARMACEUTICI Srl
- 🇮🇹BROKAST*28 cpr rivestite 10 mgAGIPS FARMACEUTICI Srl
- 🇮🇹ELUNKAST*28 cpr rivestite 10 mgPIAM FARMACEUTICI SpA
- 🇮🇹LEUKAST*28 cpr mast 4 mgKONPHARMA Srl
- 🇮🇹LEUKAST*28 cpr mast 5 mgKONPHARMA Srl
- 🇮🇹LEUKAST*28 cpr rivestite 10 mgKONPHARMA Srl
- 🇮🇹LUKANOF*28 cpr rivestite 10 mgGENETIC SpA
Access this data programmatically
Query Montelukast Sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.