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United States · US · US:54838-502_823645dc-4e60-4279-97fa-ca0d1c1d7ad8
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115483850280473 mL in 1 BOTTLE, PLASTIC (54838-502-80)
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": "54838-502_823645dc-4e60-4279-97fa-ca0d1c1d7ad8",
"productndc": "54838-502",
"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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