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United States · US · US:68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74e
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168999050242 TRAY in 1 BOX (68999-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52)
Annotations
Orange Book
A087294
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": "68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74e",
"productndc": "68999-050",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "087294",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Apr 12, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "HYDROXYZINE HYDROCHLORIDE",
"active_ingred_unit": "mg/25mL",
"application_number": "ANDA087294",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROXYZINE HYDROCHLORIDE",
"start_marketing_date": "19820412",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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