Back to search
🇺🇸

United States · US · US:0904-6808_4a289de2-d2e7-416d-9168-7f79cbff500b

Montelukast Sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

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

Packs · 2

  • ndc11
    0904680806
    50 BLISTER PACK in 1 CARTON (0904-6808-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0904680861
    100 BLISTER PACK in 1 CARTON (0904-6808-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "0904-6808_4a289de2-d2e7-416d-9168-7f79cbff500b",
  "productndc": "0904-6808",
  "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": "20140910",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R03DC53.

Access this data programmatically

Query Montelukast Sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.