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United States · US · US:29300-131_24b4fbb6-3d16-48f7-864c-71e85813a9a2
zaleplon
Orange BookUNIISPLATC N05CF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeN05CF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112930013101100 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-01)
- ndc112930013105500 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-05)
- ndc11293001311330 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-13)
Annotations
UNII (FDA Substance ID)
S62U433RMH
ZALEPLON
RxCUI 74667
Orange Book
A078989
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": "29300-131_24b4fbb6-3d16-48f7-864c-71e85813a9a2",
"productndc": "29300-131",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078989",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jun 6, 2008"
},
{
"rs": true,
"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": "ANDA078989",
"marketing_category": "ANDA",
"nonproprietary_name": "zaleplon",
"start_marketing_date": "20090505",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05CF03.
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