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United States · US · US:71335-0935_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
- ndc11713350935130 TABLET, FILM COATED in 1 BOTTLE (71335-0935-1)
- ndc11713350935260 TABLET, FILM COATED in 1 BOTTLE (71335-0935-2)
- ndc11713350935320 TABLET, FILM COATED in 1 BOTTLE (71335-0935-3)
- ndc117133509354100 TABLET, FILM COATED in 1 BOTTLE (71335-0935-4)
- ndc11713350935515 TABLET, FILM COATED in 1 BOTTLE (71335-0935-5)
- ndc11713350935690 TABLET, FILM COATED in 1 BOTTLE (71335-0935-6)
- ndc11713350935719 TABLET, FILM COATED in 1 BOTTLE (71335-0935-7)
- ndc11713350935810 TABLET, FILM COATED in 1 BOTTLE (71335-0935-8)
Annotations
Orange Book
A088618
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": "71335-0935_8a3da07e-0bfc-4d10-9dd9-11a19486fff7",
"productndc": "71335-0935",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "088618",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"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": "ANDA088618",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20121009",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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