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United States · US · US:68788-7854_e3a724e1-eb77-4678-898d-d3ad022b19b8
Hydroxyzine hydrochloride
Orange BookUNIISPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Incl
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11687887854330 TABLET in 1 BOTTLE (68788-7854-3)
- ndc11687887854660 TABLET in 1 BOTTLE (68788-7854-6)
- ndc11687887854990 TABLET in 1 BOTTLE (68788-7854-9)
Annotations
UNII (FDA Substance ID)
76755771U3
HYDROXYZINE HYDROCHLORIDE
RxCUI 154987
Orange Book
A204279
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "76755771U3",
"rxcui": "154987",
"inchikey": "ANOMHKZSQFYSBR-UHFFFAOYSA-N",
"display_name": "HYDROXYZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "68788-7854_e3a724e1-eb77-4678-898d-d3ad022b19b8",
"productndc": "68788-7854",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204279",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 20, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 20, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Aug 20, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE HYDROCHLORIDE",
"proprietary_name": "Hydroxyzine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204279",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine hydrochloride",
"start_marketing_date": "20210129",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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