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United States · US · US:10702-012_eff46bea-a884-5878-e053-2a95a90ae664
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKVK-Tech, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111070201201100 TABLET, FILM COATED in 1 BOTTLE (10702-012-01)
- ndc1110702012101000 TABLET, FILM COATED in 1 BOTTLE (10702-012-10)
- ndc111070201250500 TABLET, FILM COATED in 1 BOTTLE (10702-012-50)
Annotations
Orange Book
A040786
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": "10702-012_eff46bea-a884-5878-e053-2a95a90ae664",
"productndc": "10702-012",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040786",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 20, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Mar 20, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Mar 20, 2007"
}
],
"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": "ANDA040786",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20120724",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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