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United States · US · US:0517-4201_83de333d-1bf1-4168-8614-6bc79c26d5d0
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11051742012525 VIAL, SINGLE-DOSE in 1 TRAY (0517-4201-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-4201-01)
Annotations
Orange Book
A087408
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRAMUSCULAR",
"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": "0517-4201_83de333d-1bf1-4168-8614-6bc79c26d5d0",
"productndc": "0517-4201",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "087408",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA087408",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "19900930",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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