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United States · US · US:17856-0507_34f4870b-c857-c0d9-e063-6294a90a011a
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11178560507172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2)
Annotations
Orange Book
A201674
AA
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": "17856-0507_34f4870b-c857-c0d9-e063-6294a90a011a",
"productndc": "17856-0507",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "201674",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Aug 21, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA201674",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20130821",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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