Ambien

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0713550101
100 TABLET, COATED in 1 BOTTLE (0713-5501-01)

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": "0713-5501_2d9350bd-56ea-7273-e063-6394a90a0e61",
  "productndc": "0713-5501",
  "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": "20250207",
  "active_numerator_strength": "6.25"
}

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