MONTELUKAST SODIUM

{
  "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": "72189-418_2c4d0d3f-0096-e010-e063-6294a90a1ae9",
  "productndc": "72189-418",
  "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 SODIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202843",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MONTELUKAST SODIUM",
  "start_marketing_date": "20230202",
  "active_numerator_strength": "10"
}