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United States · US · US:83745-232_832542b8-0454-465e-a50d-a749dcd1a84d
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAPOZEAL PHARMACEUTICALS INC
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118374523216473 mL in 1 BOTTLE (83745-232-16)
Annotations
Orange Book
A210634
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": "83745-232_832542b8-0454-465e-a50d-a749dcd1a84d",
"productndc": "83745-232",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "210634",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Feb 26, 2019"
}
],
"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": "ANDA210634",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROXYZINE HYDROCHLORIDE",
"start_marketing_date": "20240716",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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