🇺🇸
United States · US · US:62135-781_462a5e7c-f204-7e57-e063-6294a90a896e
MONTELUKAST SODIUM
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621357813030 TABLET, CHEWABLE in 1 BOTTLE (62135-781-30)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A200405
ABAB
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": "62135-781_462a5e7c-f204-7e57-e063-6294a90a896e",
"productndc": "62135-781",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "200405",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "001",
"approval_date": "Aug 3, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Aug 3, 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": "ANDA200405",
"marketing_category": "ANDA",
"nonproprietary_name": "MONTELUKAST SODIUM",
"start_marketing_date": "20120803",
"active_numerator_strength": "4"
}Related drugs
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