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United States · US · US:10135-812_31a907fc-2be0-1219-e063-6294a90ac00f
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarlex Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111013581201100 TABLET, FILM COATED in 1 BOTTLE (10135-812-01)
- ndc1110135812101000 TABLET, FILM COATED in 1 BOTTLE (10135-812-10)
Annotations
Orange Book
A207121
ABABAB
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": "10135-812_31a907fc-2be0-1219-e063-6294a90ac00f",
"productndc": "10135-812",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207121",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 29, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 29, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Mar 29, 2017"
}
],
"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": "ANDA207121",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine hydrochloride",
"start_marketing_date": "20250301",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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