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United States · US · US:11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSunrise Pharmaceutical, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111153420401100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01)
- ndc1111534204031000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03)
- ndc111153420404500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04)
Annotations
Orange Book
A207121
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": "11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0",
"productndc": "11534-204",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207121",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 29, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 29, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Mar 29, 2017"
}
],
"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": "ANDA207121",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine hydrochloride",
"start_marketing_date": "20240416",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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