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United States · US · US:71335-0514_dd8189d6-e479-4e78-812c-523db9c3bdae
Montelukast Sodium
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
- ndc11713350514130 TABLET, FILM COATED in 1 BOTTLE (71335-0514-1)
- ndc1171335051424 TABLET, FILM COATED in 1 BOTTLE (71335-0514-2)
- ndc1171335051437 TABLET, FILM COATED in 1 BOTTLE (71335-0514-3)
- ndc11713350514460 TABLET, FILM COATED in 1 BOTTLE (71335-0514-4)
- ndc11713350514510 TABLET, FILM COATED in 1 BOTTLE (71335-0514-5)
- ndc11713350514690 TABLET, FILM COATED in 1 BOTTLE (71335-0514-6)
- ndc117133505147120 TABLET, FILM COATED in 1 BOTTLE (71335-0514-7)
- ndc11713350514815 TABLET, FILM COATED in 1 BOTTLE (71335-0514-8)
Annotations
UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A202717
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": "71335-0514_dd8189d6-e479-4e78-812c-523db9c3bdae",
"productndc": "71335-0514",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202717",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Sep 21, 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": "ANDA202717",
"marketing_category": "ANDA",
"nonproprietary_name": "Montelukast Sodium",
"start_marketing_date": "20130411",
"active_numerator_strength": "10"
}Related drugs
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- 🇮🇹LUKANOF*28 cpr rivestite 10 mgGENETIC SpA
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