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United States · US · US:71335-1995_b80634d9-520e-4dd5-920a-76445d9e0c87
montelukast sodium
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11713351995130 TABLET, FILM COATED in 1 BOTTLE (71335-1995-1)
- ndc1171335199524 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2)
- ndc1171335199537 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3)
- ndc11713351995460 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4)
- ndc11713351995510 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5)
- ndc11713351995690 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6)
- ndc117133519957120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7)
- ndc11713351995815 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A204290
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": "71335-1995_b80634d9-520e-4dd5-920a-76445d9e0c87",
"productndc": "71335-1995",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204290",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Oct 8, 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": "ANDA204290",
"marketing_category": "ANDA",
"nonproprietary_name": "montelukast sodium",
"start_marketing_date": "20160101",
"active_numerator_strength": "10"
}Related drugs
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