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United States · US · US:71335-2776_d7019ffc-0367-4a98-bbe2-ecd6efca509c
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
- ndc11713352776130 TABLET, FILM COATED in 1 BOTTLE (71335-2776-1)
- ndc11713352776260 TABLET, FILM COATED in 1 BOTTLE (71335-2776-2)
- ndc11713352776320 TABLET, FILM COATED in 1 BOTTLE (71335-2776-3)
- ndc117133527764100 TABLET, FILM COATED in 1 BOTTLE (71335-2776-4)
- ndc11713352776515 TABLET, FILM COATED in 1 BOTTLE (71335-2776-5)
- ndc11713352776690 TABLET, FILM COATED in 1 BOTTLE (71335-2776-6)
- ndc11713352776719 TABLET, FILM COATED in 1 BOTTLE (71335-2776-7)
- ndc11713352776810 TABLET, FILM COATED in 1 BOTTLE (71335-2776-8)
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": "71335-2776_d7019ffc-0367-4a98-bbe2-ecd6efca509c",
"productndc": "71335-2776",
"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": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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