ZOLPIDEM TARTRATE

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7161083930
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-30)
ndc11
7161083953
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-53)
ndc11
7161083960
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-60)
ndc11
7161083980
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-80)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A078970

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": "71610-839_1a8a808c-982f-49a8-e063-6294a90aa348",
  "productndc": "71610-839",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078970",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6.25MG",
        "product_no": "001",
        "approval_date": "Sep 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "002",
        "approval_date": "Sep 11, 2013"
      }
    ],
    "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": "ANDA078970",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zolpidem Tartrate",
  "start_marketing_date": "20140411",
  "active_numerator_strength": "6.25"
}

Related drugs

Other records sharing ATC code N05CF02.

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