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United States · US · US:71335-2698_acb17086-1db0-4e39-826b-45ca84eb73d8

Eszopiclone

In shortageOrange BookUNIISPLATC N05CF04

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05CF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7133526981
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2698-1)
  • ndc11
    7133526982
    60 TABLET, FILM COATED in 1 BOTTLE (71335-2698-2)
  • ndc11
    7133526983
    28 TABLET, FILM COATED in 1 BOTTLE (71335-2698-3)

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": "71335-2698_acb17086-1db0-4e39-826b-45ca84eb73d8",
  "productndc": "71335-2698",
  "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": "2"
}

Related drugs

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