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United States · US · US:72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1

Montelukast

In shortageOrange BookUNIISPLATC R03DC53

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerXLCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03DC53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7286517510
    1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10)
  • ndc11
    7286517530
    30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30)
  • ndc11
    7286517590
    90 TABLET, FILM COATED in 1 BOTTLE (72865-175-90)

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": "72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1",
  "productndc": "72865-175",
  "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": "20210211",
  "active_numerator_strength": "10"
}

Related drugs

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