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United States · US · US:71335-0268_38b4b826-574c-41c4-b201-cb6536b70f6e
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
- ndc11713350268130 TABLET in 1 BOTTLE (71335-0268-1)
- ndc117133502682100 TABLET in 1 BOTTLE (71335-0268-2)
- ndc11713350268320 TABLET in 1 BOTTLE (71335-0268-3)
- ndc11713350268490 TABLET in 1 BOTTLE (71335-0268-4)
- ndc11713350268515 TABLET in 1 BOTTLE (71335-0268-5)
- ndc11713350268660 TABLET in 1 BOTTLE (71335-0268-6)
- ndc117133502687120 TABLET in 1 BOTTLE (71335-0268-7)
- ndc11713350268810 TABLET in 1 BOTTLE (71335-0268-8)
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": "71335-0268_38b4b826-574c-41c4-b201-cb6536b70f6e",
"productndc": "71335-0268",
"dosage_form": "TABLET",
"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": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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