Montelukast Sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4306338121
21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21)
ndc11
4306338130
30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30)

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": "43063-381_509acd9d-2a2a-42e5-e063-6294a90a5b42",
  "productndc": "43063-381",
  "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": "4"
}

Related drugs

Other records sharing ATC code R03DC53.

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