Edluar

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0037605093
5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

N021997

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WY6W63843K",
    "rxcui": "221183",
    "inchikey": "VXRDAMSNTXUHFX-CEAXSRTFSA-N",
    "display_name": "ZOLPIDEM TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a32884d0-85b5-11de-8a39-0800200c9a66": {
      "match": "brand_token",
      "title": "EDLUAR (ZOLPIDEM TARTRATE) TABLET [VIATRIS SPECIALTY LLC]",
      "spl_version": "22",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0037-6050_f9d32621-9e2f-4dbf-8189-c5ab3168b5d2",
  "productndc": "0037-6050",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021997",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 13, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 13, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLPIDEM TARTRATE",
  "proprietary_name": "Edluar",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021997",
  "marketing_category": "NDA",
  "nonproprietary_name": "Zolpidem Tartrate",
  "start_marketing_date": "20090724",
  "active_numerator_strength": "5"
}

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