Zolpidem Tartrate

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8042500611
30 TABLET, FILM COATED in 1 BOTTLE (80425-0061-1)
ndc11
8042500612
60 TABLET, FILM COATED in 1 BOTTLE (80425-0061-2)
ndc11
8042500613
90 TABLET, FILM COATED in 1 BOTTLE (80425-0061-3)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A078413

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": {
    "b49f6c18-e155-4728-a79a-9354e8c3c8f4": {
      "match": "brand_token",
      "title": "ZOLPIDEM TARTRATE CAPSULE [UMEDICA LABORATORIES USA INC.]",
      "spl_version": "2",
      "published_date": "2026-05-27"
    }
  },
  "productid": "80425-0061_2a98ff70-0363-7169-e063-6394a90adc74",
  "productndc": "80425-0061",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078413",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 4, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 4, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLPIDEM TARTRATE",
  "proprietary_name": "Zolpidem Tartrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078413",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zolpidem Tartrate",
  "start_marketing_date": "20070504",
  "active_numerator_strength": "10"
}

Related drugs

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