MONTELUKAST

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6318762630
30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30)
ndc11
6318762660
60 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60)
ndc11
6318762690
90 TABLET, CHEWABLE in 1 BOTTLE (63187-626-90)

Annotations

UNII (FDA Substance ID)

U1O3J18SFL

MONTELUKAST SODIUM

RxCUI 115713

Orange Book

A203037

ABAB

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": "63187-626_b54fe609-9c8c-4ca3-bd5c-8f3ab197f969",
  "productndc": "63187-626",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "203037",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Oct 30, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Oct 30, 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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203037",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MONTELUKAST",
  "start_marketing_date": "20141201",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R03DC53.

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