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 · 6

ndc11
7642041700
1000 TABLET, FILM COATED in 1 BOTTLE (76420-417-00)
ndc11
7642041701
100 TABLET, FILM COATED in 1 BOTTLE (76420-417-01)
ndc11
7642041705
500 TABLET, FILM COATED in 1 BOTTLE (76420-417-05)
ndc11
7642041730
30 TABLET, FILM COATED in 1 BOTTLE (76420-417-30)
ndc11
7642041760
60 TABLET, FILM COATED in 1 BOTTLE (76420-417-60)
ndc11
7642041790
90 TABLET, FILM COATED in 1 BOTTLE (76420-417-90)

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": "76420-417_3aa8cb56-eaef-625f-e063-6394a90a52ea",
  "productndc": "76420-417",
  "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

Other records sharing ATC code N05CF02.

Access this data programmatically

Query Zolpidem Tartrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs