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United States · US · US:71335-1979_cf8b88f1-1781-4f41-ae5d-15641554fa75
Montelukast
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
- ndc11713351979130 TABLET, FILM COATED in 1 BOTTLE (71335-1979-1)
- ndc1171335197924 TABLET, FILM COATED in 1 BOTTLE (71335-1979-2)
- ndc1171335197937 TABLET, FILM COATED in 1 BOTTLE (71335-1979-3)
- ndc11713351979460 TABLET, FILM COATED in 1 BOTTLE (71335-1979-4)
- ndc11713351979510 TABLET, FILM COATED in 1 BOTTLE (71335-1979-5)
- ndc11713351979690 TABLET, FILM COATED in 1 BOTTLE (71335-1979-6)
- ndc117133519797120 TABLET, FILM COATED in 1 BOTTLE (71335-1979-7)
- ndc11713351979815 TABLET, FILM COATED in 1 BOTTLE (71335-1979-8)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A202843
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": "71335-1979_cf8b88f1-1781-4f41-ae5d-15641554fa75",
"productndc": "71335-1979",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202843",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Sep 10, 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": "ANDA202843",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast",
"start_marketing_date": "20140910",
"active_numerator_strength": "10"
}Related drugs
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