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United States · US · US:63187-494_ee6acff5-b3af-457d-bc54-b822635405a3
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116318749404118 mL in 1 BOTTLE, PLASTIC (63187-494-04)
Annotations
Orange Book
A087294
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": "63187-494_ee6acff5-b3af-457d-bc54-b822635405a3",
"productndc": "63187-494",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "087294",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Apr 12, 1982"
}
],
"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": "ANDA087294",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "19950309",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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