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United States · US · US:68788-8707_4084b80d-3824-410e-a992-1632c8a0ce9b
HYDROXYZINE HYDROCHLORIDE
Orange BookUNIISPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11687888707330 TABLET, FILM COATED in 1 BOTTLE (68788-8707-3)
- ndc11687888707660 TABLET, FILM COATED in 1 BOTTLE (68788-8707-6)
- ndc11687888707990 TABLET, FILM COATED in 1 BOTTLE (68788-8707-9)
Annotations
UNII (FDA Substance ID)
76755771U3
HYDROXYZINE HYDROCHLORIDE
RxCUI 154987
Orange Book
A217652
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": "68788-8707_4084b80d-3824-410e-a992-1632c8a0ce9b",
"productndc": "68788-8707",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217652",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 17, 2023"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Aug 17, 2023"
}
],
"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": "ANDA217652",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine hydrochloride",
"start_marketing_date": "20240701",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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