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United States · US · US:16714-081_1a8febc0-9d51-4026-8ea6-6cba69e841c5
HydrOXYzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar RxLLC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111671408110100 TABLET in 1 BOTTLE (16714-081-10)
- ndc111671408111500 TABLET in 1 BOTTLE (16714-081-11)
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": "16714-081_1a8febc0-9d51-4026-8ea6-6cba69e841c5",
"productndc": "16714-081",
"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.
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