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United States · US · US:71335-2468_5cbad0f1-c66b-4bd0-bfb0-530333c5e4d5
Zaleplon
Orange BookUNIISPLATC N05CF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05CF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11713352468115 CAPSULE in 1 BOTTLE (71335-2468-1)
- ndc11713352468230 CAPSULE in 1 BOTTLE (71335-2468-2)
- ndc11713352468360 CAPSULE in 1 BOTTLE (71335-2468-3)
- ndc11713352468490 CAPSULE in 1 BOTTLE (71335-2468-4)
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": "71335-2468_5cbad0f1-c66b-4bd0-bfb0-530333c5e4d5",
"productndc": "71335-2468",
"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": "10"
}Related drugs
Other records sharing ATC code N05CF03.
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