Ambien

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerSanofi-Aventis U.S. LLC

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

N021774

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": {
    "c36cadf4-65a4-4466-b409-c82020b42452": {
      "match": "brand_token",
      "title": "AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "26",
      "published_date": "2025-04-18"
    }
  },
  "productid": "0024-5521_3781baee-63d5-40a7-bc44-fc72d1adca32",
  "productndc": "0024-5521",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "021774",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Sep 2, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "6.25MG",
        "product_no": "002",
        "approval_date": "Sep 2, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLPIDEM TARTRATE",
  "proprietary_name": "Ambien",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021774",
  "marketing_category": "NDA",
  "nonproprietary_name": "zolpidem tartrate",
  "start_marketing_date": "20050919",
  "active_numerator_strength": "12.5"
}

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