Montelukast Sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1366808005
500 TABLET, CHEWABLE in 1 BOTTLE (13668-080-05)
ndc11
1366808030
30 TABLET, CHEWABLE in 1 BOTTLE (13668-080-30)
ndc11
1366808090
90 TABLET, CHEWABLE in 1 BOTTLE (13668-080-90)

Annotations

UNII (FDA Substance ID)

U1O3J18SFL

MONTELUKAST SODIUM

RxCUI 115713

Orange Book

A090984

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": "13668-080_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a",
  "productndc": "13668-080",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "090984",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Aug 3, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Aug 3, 2012"
      }
    ],
    "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": "ANDA090984",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Montelukast Sodium",
  "start_marketing_date": "20120803",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R03DC53.

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