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United States · US · US:33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6
Montelukast
In shortageOrange BookUNIISPLATC R03DC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeR03DC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11333421020730 TABLET in 1 BOTTLE (33342-102-07)
- ndc11333421021090 TABLET in 1 BOTTLE (33342-102-10)
- ndc113334210212100 TABLET in 1 BLISTER PACK (33342-102-12)
- ndc113334210215500 TABLET in 1 BOTTLE (33342-102-15)
- ndc11333421023990 TABLET in 1 BLISTER PACK (33342-102-39)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A203366
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": "33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6",
"productndc": "33342-102",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203366",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Sep 11, 2014"
}
],
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203366",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast",
"start_marketing_date": "20140911",
"active_numerator_strength": "10"
}Related drugs
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