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United States · US · US:0024-5421_3d6feaca-4f30-4ca9-a9c8-d9038744fa2f
Ambien
Orange BookUNIISPLATC N05CF02
Last synced from FDA National Drug Code directory (United States) on
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
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": "0024-5421_3d6feaca-4f30-4ca9-a9c8-d9038744fa2f",
"productndc": "0024-5421",
"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": "19930401",
"active_numerator_strength": "10"
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