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United States · US · US:69452-395_39f93640-6535-6c3b-e063-6394a90a7f2d
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116945239588473 mL in 1 BOTTLE (69452-395-88)
Annotations
Orange Book
A219289
AA
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": "69452-395_39f93640-6535-6c3b-e063-6394a90a7f2d",
"productndc": "69452-395",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219289",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Apr 28, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA219289",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride Oral",
"start_marketing_date": "20250717",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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