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United States · US · US:52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419dae
zolpidem tartrate
Orange BookUNIISPLATC N05CF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlmatica Pharma LLC
CountryUS (United States)
ATC codeN05CF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11524277753030 CAPSULE in 1 BOTTLE (52427-775-30)
Annotations
UNII (FDA Substance ID)
WY6W63843K
ZOLPIDEM TARTRATE
RxCUI 221183
Orange Book
N215721
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": "52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419dae",
"productndc": "52427-775",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215721",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "7.5MG",
"product_no": "001",
"approval_date": "May 9, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZOLPIDEM TARTRATE",
"proprietary_name": "zolpidem tartrate",
"active_ingred_unit": "mg/1",
"application_number": "NDA215721",
"marketing_category": "NDA",
"nonproprietary_name": "zolpidem tartrate",
"start_marketing_date": "20230509",
"active_numerator_strength": "7.5"
}Related drugs
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