Montelukast sodium

In shortageOrange BookUNIISPLATC R03DC53

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
3334211107
30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07)
ndc11
3334211110
90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10)
ndc11
3334211112
100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12)
ndc11
3334211115
500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15)
ndc11
3334211139
90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39)
ndc11
3334211144
1000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44)

Annotations

UNII (FDA Substance ID)

MHM278SD3E

MONTELUKAST

RxCUI 88249

Orange Book

A203582

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Montelukast Sodium Tablet, Chewable

Raw payload (JSON)

{
  "unii": {
    "unii": "MHM278SD3E",
    "rxcui": "88249",
    "inchikey": "UCHDWCPVSPXUMX-TZIWLTJVSA-N",
    "display_name": "MONTELUKAST",
    "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": "33342-111_a12af8c6-41af-4850-b725-4f8226b35b67",
  "productndc": "33342-111",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "203582",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Mar 12, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Mar 12, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MONTELUKAST",
  "shortage_reason": "Montelukast Sodium Tablet, Chewable",
  "shortage_status": "current",
  "proprietary_name": "Montelukast sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203582",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Montelukast sodium",
  "start_marketing_date": "20150313",
  "active_numerator_strength": "5"
}

Related drugs

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