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United States · US · US:50090-7330_4278def4-d310-40ba-a058-2b4f21b9d8ec
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 · 4
- ndc11500907330020 TABLET, FILM COATED in 1 BOTTLE (50090-7330-0)
- ndc11500907330130 TABLET, FILM COATED in 1 BOTTLE (50090-7330-1)
- ndc11500907330460 TABLET, FILM COATED in 1 BOTTLE (50090-7330-4)
- ndc11500907330615 TABLET, FILM COATED in 1 BOTTLE (50090-7330-6)
Annotations
Orange Book
A217652
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": "50090-7330_4278def4-d310-40ba-a058-2b4f21b9d8ec",
"productndc": "50090-7330",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217652",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 17, 2023"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Aug 17, 2023"
}
],
"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": "ANDA217652",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine hydrochloride",
"start_marketing_date": "20230822",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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