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United States · US · US:71205-083_6eebea17-bc98-49a2-854c-35267194f4c4
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11712050831515 TABLET, FILM COATED in 1 BOTTLE (71205-083-15)
- ndc11712050832020 TABLET, FILM COATED in 1 BOTTLE (71205-083-20)
- ndc11712050833030 TABLET, FILM COATED in 1 BOTTLE (71205-083-30)
- ndc11712050836060 TABLET, FILM COATED in 1 BOTTLE (71205-083-60)
- ndc11712050839090 TABLET, FILM COATED in 1 BOTTLE (71205-083-90)
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": "71205-083_6eebea17-bc98-49a2-854c-35267194f4c4",
"productndc": "71205-083",
"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 Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA088619",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20121022",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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