montelukast sodium

In shortageOrange BookUNIISPLATC R03DC53

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.

CountryUS (United States)

ATC codeR03DC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
2930022210
1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-10)
ndc11
2930022213
30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-13)
ndc11
2930022219
90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-19)

Annotations

UNII (FDA Substance ID)

U1O3J18SFL

MONTELUKAST SODIUM

RxCUI 115713

Orange Book

A208621

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": "29300-222_57f07f65-1a14-4423-9da8-975664ca0684",
  "productndc": "29300-222",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "208621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Jul 2, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 2, 2018"
      }
    ],
    "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": "ANDA208621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "montelukast sodium",
  "start_marketing_date": "20180820",
  "active_numerator_strength": "5"
}

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