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United States · US · US:71335-3088_8db62cda-c456-47b3-85bb-b67f777c0a9a
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11713353088130 TABLET, FILM COATED in 1 BOTTLE (71335-3088-1)
- ndc117133530882100 TABLET, FILM COATED in 1 BOTTLE (71335-3088-2)
- ndc11713353088320 TABLET, FILM COATED in 1 BOTTLE (71335-3088-3)
- ndc11713353088490 TABLET, FILM COATED in 1 BOTTLE (71335-3088-4)
- ndc11713353088515 TABLET, FILM COATED in 1 BOTTLE (71335-3088-5)
- ndc11713353088660 TABLET, FILM COATED in 1 BOTTLE (71335-3088-6)
- ndc117133530887120 TABLET, FILM COATED in 1 BOTTLE (71335-3088-7)
- ndc11713353088810 TABLET, FILM COATED in 1 BOTTLE (71335-3088-8)
Annotations
Orange Book
A087871
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": "71335-3088_8db62cda-c456-47b3-85bb-b67f777c0a9a",
"productndc": "71335-3088",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "087871",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 20, 1982"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 20, 1982"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Dec 20, 1982"
}
],
"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": "ANDA087871",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20211007",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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