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United States · US · US:71335-0961_8a3da07e-0bfc-4d10-9dd9-11a19486fff7
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
- ndc11713350961130 TABLET, FILM COATED in 1 BOTTLE (71335-0961-1)
- ndc117133509612100 TABLET, FILM COATED in 1 BOTTLE (71335-0961-2)
- ndc11713350961320 TABLET, FILM COATED in 1 BOTTLE (71335-0961-3)
- ndc11713350961490 TABLET, FILM COATED in 1 BOTTLE (71335-0961-4)
- ndc11713350961515 TABLET, FILM COATED in 1 BOTTLE (71335-0961-5)
- ndc11713350961660 TABLET, FILM COATED in 1 BOTTLE (71335-0961-6)
- ndc117133509617120 TABLET, FILM COATED in 1 BOTTLE (71335-0961-7)
- ndc11713350961810 TABLET, FILM COATED in 1 BOTTLE (71335-0961-8)
Annotations
Orange Book
A088617
AB
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": "71335-0961_8a3da07e-0bfc-4d10-9dd9-11a19486fff7",
"productndc": "71335-0961",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "088617",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 10, 1986"
}
],
"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": "ANDA088617",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20130219",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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