ZOLPIDEM TARTRATE

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerThe ACME Laboratories Ltd.

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7272210301
30 TABLET, FILM COATED in 1 BOTTLE (72722-103-01)
ndc11
7272210305
100 TABLET, FILM COATED in 1 BOTTLE (72722-103-05)
ndc11
7272210307
1000 TABLET, FILM COATED in 1 BOTTLE (72722-103-07)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A077214

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": "72722-103_745d297b-54a1-4d6f-8f60-44cbbdc0e758",
  "productndc": "72722-103",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077214",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 23, 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": "ANDA077214",
  "marketing_category": "ANDA",
  "nonproprietary_name": "zolpidem tartrate",
  "start_marketing_date": "20200924",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05CF02.

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