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United States · US · US:42806-160_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEpic Pharma, LLC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114280616001100 TABLET, FILM COATED in 1 BOTTLE (42806-160-01)
- ndc114280616005500 TABLET, FILM COATED in 1 BOTTLE (42806-160-05)
- ndc1142806160101000 TABLET, FILM COATED in 1 BOTTLE (42806-160-10)
Annotations
Orange Book
A040604
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"4cd84205-6a33-db48-e063-6394a90a9182": {
"match": "brand_token",
"title": "HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "42806-160_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3",
"productndc": "42806-160",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040604",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 28, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 28, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Dec 28, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040604",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20150331",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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