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United States · US · US:65862-214_36ab371f-c2fe-4c1d-ad60-801b8f118f4e
ZALEPLON
Orange BookUNIISPLATC N05CF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05CF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586221401100 CAPSULE in 1 BOTTLE (65862-214-01)
- ndc116586221405500 CAPSULE in 1 BOTTLE (65862-214-05)
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": "65862-214_36ab371f-c2fe-4c1d-ad60-801b8f118f4e",
"productndc": "65862-214",
"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.
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