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United States · US · US:59651-500_86a715f8-fbfb-4d28-a144-27581d6aa1bb
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115965150001100 TABLET, FILM COATED in 1 BOTTLE (59651-500-01)
- ndc115965150005500 TABLET, FILM COATED in 1 BOTTLE (59651-500-05)
- ndc1159651500991000 TABLET, FILM COATED in 1 BOTTLE (59651-500-99)
Annotations
Orange Book
A087871
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": "59651-500_86a715f8-fbfb-4d28-a144-27581d6aa1bb",
"productndc": "59651-500",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "087871",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 20, 1982"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 20, 1982"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Dec 20, 1982"
}
],
"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": "ANDA087871",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20211007",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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