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United States · US · US:24658-783_384448bf-baa4-482b-91cd-585b03c62907
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124658783101000 TABLET, FILM COATED in 1 BOTTLE (24658-783-10)
Annotations
Orange Book
A040604
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": "24658-783_384448bf-baa4-482b-91cd-585b03c62907",
"productndc": "24658-783",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040604",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 28, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 28, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Dec 28, 2004"
}
],
"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": "ANDA040604",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20210721",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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