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United States · US · US:80425-0173_16edd342-ced2-eeb7-e063-6394a90a35ef
Hydroxyzine HCL
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11804250173130 TABLET, FILM COATED in 1 BOTTLE (80425-0173-1)
- ndc11804250173260 TABLET, FILM COATED in 1 BOTTLE (80425-0173-2)
Annotations
Orange Book
A088619
AB
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": "80425-0173_16edd342-ced2-eeb7-e063-6394a90a35ef",
"productndc": "80425-0173",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "088619",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Jan 10, 1986"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA088619",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine HCL",
"start_marketing_date": "20121022",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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