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 · 5

ndc11
7642035400
1000 TABLET, FILM COATED in 1 BOTTLE (76420-354-00)
ndc11
7642035401
100 TABLET, FILM COATED in 1 BOTTLE (76420-354-01)
ndc11
7642035430
30 TABLET, FILM COATED in 1 BOTTLE (76420-354-30)
ndc11
7642035460
60 TABLET, FILM COATED in 1 BOTTLE (76420-354-60)
ndc11
7642035490
90 TABLET, FILM COATED in 1 BOTTLE (76420-354-90)

Annotations

UNII (FDA Substance ID)

UZX80K71OE

ESZOPICLONE

RxCUI 461016

Orange Book

A091166

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": "76420-354_4ca4de13-a880-98bf-e063-6294a90aa9f2",
  "productndc": "76420-354",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091166",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Apr 15, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Apr 15, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Apr 15, 2014"
      }
    ],
    "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": "ANDA091166",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eszopiclone",
  "start_marketing_date": "20140415",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code N05CF04.

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