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United States · US · US:51655-076_46ddcf32-22fa-3332-e063-6394a90af421
Hydroxyzine hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11516550765230 TABLET in 1 BOTTLE, PLASTIC (51655-076-52)
- ndc11516550765415 TABLET in 1 BOTTLE, PLASTIC (51655-076-54)
Annotations
Orange Book
A204279
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": "51655-076_46ddcf32-22fa-3332-e063-6394a90af421",
"productndc": "51655-076",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204279",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 20, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 20, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Aug 20, 2014"
}
],
"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": "ANDA204279",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine hydrochloride",
"start_marketing_date": "20201020",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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