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United States · US · US:65162-577_6c929cf4-2a16-4956-b410-8e44db920604
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116516257710100 TABLET, FILM COATED in 1 BOTTLE (65162-577-10)
- ndc1165162577111000 TABLET, FILM COATED in 1 BOTTLE (65162-577-11)
- ndc116516257750500 TABLET, FILM COATED in 1 BOTTLE (65162-577-50)
Annotations
Orange Book
A040808
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": "65162-577_6c929cf4-2a16-4956-b410-8e44db920604",
"productndc": "65162-577",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040808",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 24, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "002",
"approval_date": "Sep 24, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "003",
"approval_date": "Sep 24, 2008"
}
],
"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": "ANDA040808",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine",
"start_marketing_date": "20080924",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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