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United States · US · US:81033-031_4cac7248-0970-077a-e063-6294a90a782d
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKesin Pharma
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11810330314440 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05)
- ndc11810330314540 CUP, UNIT-DOSE in 1 CARTON (81033-031-45) / 12.5 mL in 1 CUP, UNIT-DOSE (81033-031-12)
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": "81033-031_4cac7248-0970-077a-e063-6294a90a782d",
"productndc": "81033-031",
"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",
"start_marketing_date": "20250717",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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