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United States · US · US:55111-725_8bc013e8-5324-099d-e603-d78012b126bd
Montelukast Sodium
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Limited
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115511172501100 TABLET, COATED in 1 BOTTLE (55111-725-01)
- ndc1155111725101000 TABLET, COATED in 1 BOTTLE (55111-725-10)
- ndc11551117253030 TABLET, COATED in 1 BOTTLE (55111-725-30)
- ndc11551117257810 BLISTER PACK in 1 CARTON (55111-725-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-725-79)
- ndc11551117259090 TABLET, COATED in 1 BOTTLE (55111-725-90)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A201582
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": "55111-725_8bc013e8-5324-099d-e603-d78012b126bd",
"productndc": "55111-725",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "201582",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Aug 6, 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": "ANDA201582",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast Sodium",
"start_marketing_date": "20120806",
"active_numerator_strength": "10"
}Related drugs
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