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United States · US · US:68788-7169_9dec8075-bac4-4953-b317-f88ae1005a0e

Eszopiclone

In shortageOrange BookUNIISPLATC N05CF04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05CF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6878871691
    10 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1)
  • ndc11
    6878871692
    20 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2)
  • ndc11
    6878871693
    30 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3)
  • ndc11
    6878871696
    60 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6)
  • ndc11
    6878871699
    90 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9)

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": "68788-7169_9dec8075-bac4-4953-b317-f88ae1005a0e",
  "productndc": "68788-7169",
  "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": "20180611",
  "active_numerator_strength": "3"
}

Related drugs

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