Eszopiclone

In shortageOrange BookUNIISPLATC N05CF04

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeN05CF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5511161901
100 TABLET, COATED in 1 BOTTLE (55111-619-01)
ndc11
5511161905
500 TABLET, COATED in 1 BOTTLE (55111-619-05)
ndc11
5511161909
9 BLISTER PACK in 1 CARTON (55111-619-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-619-79)
ndc11
5511161930
30 TABLET, COATED in 1 BOTTLE (55111-619-30)
ndc11
5511161990
90 TABLET, COATED in 1 BOTTLE (55111-619-90)

Annotations

UNII (FDA Substance ID)

UZX80K71OE

ESZOPICLONE

RxCUI 461016

Orange Book

A091024

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": "55111-619_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581",
  "productndc": "55111-619",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "091024",
    "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": "ANDA091024",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eszopiclone",
  "start_marketing_date": "20140415",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N05CF04.

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