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United States · US · US:31722-502_ee32d5bd-38fb-4a93-e053-2a95a90a0464
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc113172250201100 TABLET, FILM COATED in 1 BOTTLE (31722-502-01)
- ndc113172250205500 TABLET, FILM COATED in 1 BOTTLE (31722-502-05)
- ndc1131722502101000 TABLET, FILM COATED in 1 BOTTLE (31722-502-10)
Annotations
Orange Book
A040805
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": "31722-502_ee32d5bd-38fb-4a93-e053-2a95a90a0464",
"productndc": "31722-502",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040805",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "May 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 29, 2008"
}
],
"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": "ANDA040805",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20080529",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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