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United States · US · US:0713-5421_2d934208-e709-2948-e063-6294a90aa9b6
Ambien
Orange BookUNIISPLATC N05CF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05CF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110713542101100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01)
Annotations
UNII (FDA Substance ID)
WY6W63843K
ZOLPIDEM TARTRATE
RxCUI 221183
Orange Book
N019908
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": "0713-5421_2d934208-e709-2948-e063-6294a90aa9b6",
"productndc": "0713-5421",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "019908",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Dec 16, 1992"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 16, 1992"
}
],
"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": "NDA019908",
"marketing_category": "NDA",
"nonproprietary_name": "zolpidem tartrate",
"start_marketing_date": "20250207",
"active_numerator_strength": "10"
}Related drugs
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- 🇺🇸AmbienCosette Pharmaceuticals, Inc.
- 🇺🇸AmbienSanofi-Aventis U.S. LLC
- 🇺🇸AmbienCosette Pharmaceuticals, Inc.
- 🇺🇸AmbienSanofi-Aventis U.S. LLC
- 🇺🇸AmbienSanofi-Aventis U.S. LLC
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