montelukast sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5009079200
30 TABLET, CHEWABLE in 1 BOTTLE (50090-7920-0)
ndc11
5009079201
90 TABLET, CHEWABLE in 1 BOTTLE (50090-7920-1)

Annotations

UNII (FDA Substance ID)

MHM278SD3E

MONTELUKAST

RxCUI 88249

Orange Book

A204093

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": "50090-7920_c678afd8-0ddd-40a3-936e-594c126a275d",
  "productndc": "50090-7920",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "204093",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "May 22, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "May 22, 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": "ANDA204093",
  "marketing_category": "ANDA",
  "nonproprietary_name": "montelukast sodium",
  "start_marketing_date": "20150527",
  "active_numerator_strength": "4"
}

Related drugs

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