🇺🇸
United States · US · US:31722-728_c503ea71-c663-3cfc-e053-2a95a90a9aaa
montelukast sodium
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc113172272801100 TABLET, CHEWABLE in 1 BOTTLE (31722-728-01)
- ndc1131722728101000 TABLET, CHEWABLE in 1 BOTTLE (31722-728-10)
- ndc11317227283030 TABLET, CHEWABLE in 1 BOTTLE (31722-728-30)
- ndc11317227283110 TABLET, CHEWABLE in 1 BLISTER PACK (31722-728-31)
- ndc113172272832100 TABLET, CHEWABLE in 1 CARTON (31722-728-32)
- ndc11317227289090 TABLET, CHEWABLE in 1 BOTTLE (31722-728-90)
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": "31722-728_c503ea71-c663-3cfc-e053-2a95a90a9aaa",
"productndc": "31722-728",
"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": "20150527",
"active_numerator_strength": "5"
}Related drugs
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