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United States · US · US:71335-2451_897a39b6-65b1-4e52-85e9-2650d23a4dc0
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
- ndc11713352451130 TABLET, FILM COATED in 1 BOTTLE (71335-2451-1)
- ndc11713352451260 TABLET, FILM COATED in 1 BOTTLE (71335-2451-2)
- ndc11713352451320 TABLET, FILM COATED in 1 BOTTLE (71335-2451-3)
- ndc117133524514100 TABLET, FILM COATED in 1 BOTTLE (71335-2451-4)
- ndc11713352451515 TABLET, FILM COATED in 1 BOTTLE (71335-2451-5)
- ndc11713352451690 TABLET, FILM COATED in 1 BOTTLE (71335-2451-6)
- ndc11713352451719 TABLET, FILM COATED in 1 BOTTLE (71335-2451-7)
- ndc11713352451810 TABLET, FILM COATED in 1 BOTTLE (71335-2451-8)
Annotations
Orange Book
A040786
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": "71335-2451_897a39b6-65b1-4e52-85e9-2650d23a4dc0",
"productndc": "71335-2451",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040786",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 20, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Mar 20, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Mar 20, 2007"
}
],
"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": "ANDA040786",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20120724",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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