ESZOPICLONE

In shortageOrange BookUNIISPLATC N05CF04

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05CF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6878876670
100 TABLET, FILM COATED in 1 BOTTLE (68788-7667-0)
ndc11
6878876671
10 TABLET, FILM COATED in 1 BOTTLE (68788-7667-1)
ndc11
6878876672
20 TABLET, FILM COATED in 1 BOTTLE (68788-7667-2)
ndc11
6878876673
30 TABLET, FILM COATED in 1 BOTTLE (68788-7667-3)
ndc11
6878876675
15 TABLET, FILM COATED in 1 BOTTLE (68788-7667-5)
ndc11
6878876676
60 TABLET, FILM COATED in 1 BOTTLE (68788-7667-6)
ndc11
6878876677
7 TABLET, FILM COATED in 1 BOTTLE (68788-7667-7)
ndc11
6878876679
90 TABLET, FILM COATED in 1 BOTTLE (68788-7667-9)

Annotations

UNII (FDA Substance ID)

UZX80K71OE

ESZOPICLONE

RxCUI 461016

Orange Book

A208451

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": "68788-7667_1fb749c5-2de2-4875-8a41-2eaf6747db82",
  "productndc": "68788-7667",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208451",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Sep 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Sep 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Sep 15, 2016"
      }
    ],
    "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": "ANDA208451",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ESZOPICLONE",
  "start_marketing_date": "20200228",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05CF04.

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