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United States · US · US:16571-114_20aba551-c0c0-4ea1-8200-ad81956ff294
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111657111401100 TABLET, FILM COATED in 1 BOTTLE (16571-114-01)
- ndc1116571114101000 TABLET, FILM COATED in 1 BOTTLE (16571-114-10)
- ndc111657111450500 TABLET, FILM COATED in 1 BOTTLE (16571-114-50)
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": "16571-114_20aba551-c0c0-4ea1-8200-ad81956ff294",
"productndc": "16571-114",
"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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