Eszopiclone

In shortageOrange BookUNIISPLATC N05CF04

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN05CF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642002601
100 TABLET, FILM COATED in 1 BOTTLE (76420-026-01)
ndc11
7642002610
10 TABLET, FILM COATED in 1 BOTTLE (76420-026-10)
ndc11
7642002620
20 TABLET, FILM COATED in 1 BOTTLE (76420-026-20)
ndc11
7642002630
30 TABLET, FILM COATED in 1 BOTTLE (76420-026-30)
ndc11
7642002660
60 TABLET, FILM COATED in 1 BOTTLE (76420-026-60)
ndc11
7642002690
90 TABLET, FILM COATED in 1 BOTTLE (76420-026-90)

Annotations

UNII (FDA Substance ID)

UZX80K71OE

ESZOPICLONE

RxCUI 461016

Orange Book

A202929

ABABAB

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": "76420-026_2df4e9b7-6d0c-7409-e063-6294a90a46ce",
  "productndc": "76420-026",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202929",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Jan 30, 2015"
      }
    ],
    "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": "ANDA202929",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eszopiclone",
  "start_marketing_date": "20150131",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05CF04.

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