🇺🇸
United States · US · US:57237-239_344d16be-8384-4299-995d-97b48d5d62c0
ZALEPLON
Orange BookUNIISPLATC N05CF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN05CF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115723723901100 CAPSULE in 1 BOTTLE (57237-239-01)
Annotations
UNII (FDA Substance ID)
S62U433RMH
ZALEPLON
RxCUI 74667
Orange Book
A078829
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": "57237-239_344d16be-8384-4299-995d-97b48d5d62c0",
"productndc": "57237-239",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078829",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jun 6, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jun 6, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZALEPLON",
"proprietary_name": "ZALEPLON",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078829",
"marketing_category": "ANDA",
"nonproprietary_name": "ZALEPLON",
"start_marketing_date": "20080606",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05CF03.
Access this data programmatically
Query ZALEPLON and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.