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United States · US · US:70954-912_43889411-a303-41a1-b03b-1ee46f452c54
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095491210473 mL in 1 BOTTLE (70954-912-10)
Annotations
Orange Book
A219648
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": "70954-912_43889411-a303-41a1-b03b-1ee46f452c54",
"productndc": "70954-912",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219648",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Dec 16, 2025"
}
],
"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": "ANDA219648",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20260115",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
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