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United States · US · US:68788-8725_c90005da-3a75-4408-b34d-22f2394bf01f
Zaleplon
Orange BookUNIISPLATC N05CF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05CF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878887251100 CAPSULE in 1 BOTTLE (68788-8725-1)
- ndc11687888725220 CAPSULE in 1 BOTTLE (68788-8725-2)
- ndc11687888725330 CAPSULE in 1 BOTTLE (68788-8725-3)
- ndc11687888725660 CAPSULE in 1 BOTTLE (68788-8725-6)
- ndc11687888725990 CAPSULE in 1 BOTTLE (68788-8725-9)
Annotations
UNII (FDA Substance ID)
S62U433RMH
ZALEPLON
RxCUI 74667
Orange Book
A090374
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S62U433RMH",
"rxcui": "74667",
"inchikey": "HUNXMJYCHXQEGX-UHFFFAOYSA-N",
"display_name": "ZALEPLON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b0476859-07af-47f1-aec7-61aea0d99d24": {
"match": "brand_token",
"title": "ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "8",
"published_date": "2025-11-17"
}
},
"productid": "68788-8725_c90005da-3a75-4408-b34d-22f2394bf01f",
"productndc": "68788-8725",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090374",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Sep 17, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Sep 17, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZALEPLON",
"proprietary_name": "Zaleplon",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090374",
"marketing_category": "ANDA",
"nonproprietary_name": "Zaleplon",
"start_marketing_date": "20240816",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05CF03.
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