🇺🇸
United States · US · US:50090-6682_513396a5-9d16-4198-bff7-b966a546bc51
HydrOXYzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11500906682030 TABLET in 1 BOTTLE (50090-6682-0)
- ndc11500906682320 TABLET in 1 BOTTLE (50090-6682-3)
Annotations
Orange Book
A040840
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": "50090-6682_513396a5-9d16-4198-bff7-b966a546bc51",
"productndc": "50090-6682",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040840",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Mar 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Mar 31, 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": "ANDA040840",
"marketing_category": "ANDA",
"nonproprietary_name": "HydrOXYzine Hydrochloride",
"start_marketing_date": "20091111",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
Access this data programmatically
Query HydrOXYzine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.