ZOLPIDEM TARTRATE

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7642031801
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-318-01)
ndc11
7642031830
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-318-30)
ndc11
7642031860
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-318-60)
ndc11
7642031890
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-318-90)

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": "76420-318_327e6538-4b98-1f09-e063-6294a90a2f75",
  "productndc": "76420-318",
  "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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