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United States · US · US:80425-0394_19b094e5-8afa-94c1-e063-6294a90a297f
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11804250394130 TABLET, FILM COATED in 1 BOTTLE (80425-0394-1)
- ndc11804250394260 TABLET, FILM COATED in 1 BOTTLE (80425-0394-2)
Annotations
Orange Book
A217652
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": "80425-0394_19b094e5-8afa-94c1-e063-6294a90a297f",
"productndc": "80425-0394",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217652",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 17, 2023"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Aug 17, 2023"
}
],
"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": "ANDA217652",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine hydrochloride",
"start_marketing_date": "20240524",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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