🇺🇸
United States · US · US:68788-7669_f9ab7e9f-ce5e-4c52-919e-66602d0c719e
montelukast sodium
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11687887669110 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-1)
- ndc11687887669220 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-2)
- ndc11687887669330 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-3)
- ndc11687887669414 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-4)
- ndc11687887669660 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-6)
- ndc11687887669990 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-9)
Annotations
UNII (FDA Substance ID)
MHM278SD3E
MONTELUKAST
RxCUI 88249
Orange Book
A204093
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Montelukast Sodium Tablet, Chewable
Raw payload (JSON)
{
"unii": {
"unii": "MHM278SD3E",
"rxcui": "88249",
"inchikey": "UCHDWCPVSPXUMX-TZIWLTJVSA-N",
"display_name": "MONTELUKAST",
"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": "68788-7669_f9ab7e9f-ce5e-4c52-919e-66602d0c719e",
"productndc": "68788-7669",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "204093",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "001",
"approval_date": "May 22, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "May 22, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MONTELUKAST",
"shortage_reason": "Montelukast Sodium Tablet, Chewable",
"shortage_status": "current",
"proprietary_name": "montelukast sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204093",
"marketing_category": "ANDA",
"nonproprietary_name": "montelukast sodium",
"start_marketing_date": "20200228",
"active_numerator_strength": "5"
}Related drugs
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