🇺🇸
United States · US · US:0093-5060_ce53cc7b-dd6d-4a1b-b64b-ca0b45f67512
Hydroxyzine Hydrochloride
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110093506001100 TABLET, FILM COATED in 1 BOTTLE (0093-5060-01)
- ndc110093506005500 TABLET, FILM COATED in 1 BOTTLE (0093-5060-05)
Annotations
Orange Book
A088617
AB
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": "0093-5060_ce53cc7b-dd6d-4a1b-b64b-ca0b45f67512",
"productndc": "0093-5060",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "088617",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 10, 1986"
}
],
"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": "ANDA088617",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Hydrochloride",
"start_marketing_date": "20130219",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BB01.
Access this data programmatically
Query Hydroxyzine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.