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United States · US · US:68788-8617_68ee9209-7a6b-4f51-9252-2e22baaa58f4

montelukast sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

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

Packs · 3

  • ndc11
    6878886173
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-3)
  • ndc11
    6878886176
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-6)
  • ndc11
    6878886179
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-9)

Annotations

UNII (FDA Substance ID)
U1O3J18SFL
MONTELUKAST SODIUM
RxCUI 115713
Orange Book
A204290
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": "68788-8617_68ee9209-7a6b-4f51-9252-2e22baaa58f4",
  "productndc": "68788-8617",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204290",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Oct 8, 2015"
      }
    ],
    "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": "ANDA204290",
  "marketing_category": "ANDA",
  "nonproprietary_name": "montelukast sodium",
  "start_marketing_date": "20240328",
  "active_numerator_strength": "10"
}

Related drugs

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