Eszopiclone

In shortageOrange BookUNIISPLATC N05CF04

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05CF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306379530
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30)

Annotations

UNII (FDA Substance ID)

UZX80K71OE

ESZOPICLONE

RxCUI 461016

Orange Book

A091124

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Eszopiclone Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "UZX80K71OE",
    "rxcui": "461016",
    "inchikey": "GBBSUAFBMRNDJC-INIZCTEOSA-N",
    "display_name": "ESZOPICLONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c": {
      "match": "brand_token",
      "title": "ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-25"
    }
  },
  "productid": "43063-795_415b59ae-84e5-550f-e063-6294a90af226",
  "productndc": "43063-795",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091124",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Sep 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Sep 13, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESZOPICLONE",
  "shortage_reason": "Eszopiclone Tablet",
  "shortage_status": "current",
  "proprietary_name": "Eszopiclone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091124",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eszopiclone",
  "start_marketing_date": "20140415",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code N05CF04.

Access this data programmatically

Query Eszopiclone 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