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United States · US · US:69452-364_d0929d4c-0f84-40a4-94dc-6f80934e0edf
Zaleplon
Orange BookUNIISPLATC N05CF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeN05CF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116945236420100 CAPSULE in 1 BOTTLE (69452-364-20)
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": "69452-364_d0929d4c-0f84-40a4-94dc-6f80934e0edf",
"productndc": "69452-364",
"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": "20240217",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05CF03.
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