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United States · US · US:63629-4929_9efda664-6143-4427-9290-60c6abf0ec0b
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 · 5
- ndc116362949291120 TABLET, FILM COATED in 1 BOTTLE (63629-4929-1)
- ndc11636294929220 TABLET, FILM COATED in 1 BOTTLE (63629-4929-2)
- ndc11636294929330 TABLET, FILM COATED in 1 BOTTLE (63629-4929-3)
- ndc11636294929460 TABLET, FILM COATED in 1 BOTTLE (63629-4929-4)
- ndc11636294929590 TABLET, FILM COATED in 1 BOTTLE (63629-4929-5)
Annotations
Orange Book
A204279
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": "63629-4929_9efda664-6143-4427-9290-60c6abf0ec0b",
"productndc": "63629-4929",
"dosage_form": "TABLET, FILM COATED",
"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 DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204279",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine hydrochloride",
"start_marketing_date": "20140820",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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