montelukast sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7133516021
30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1)
ndc11
7133516022
90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2)
ndc11
7133516023
60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3)

Annotations

UNII (FDA Substance ID)

U1O3J18SFL

MONTELUKAST SODIUM

RxCUI 115713

Orange Book

A204093

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": "71335-1602_640b5606-8295-4f8d-9929-aedf2f51d227",
  "productndc": "71335-1602",
  "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 SODIUM",
  "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

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.

Get a free API key Read the API docs