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United States · US · US:0555-0324_c307ca43-d41f-401b-bd15-0c753eca86e5
Hydroxyzine Pamoate
Orange BookUNIISPLATC 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 · 1
- ndc110555032402100 CAPSULE in 1 BOTTLE (0555-0324-02)
Annotations
UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A088488
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M20215MUFR",
"rxcui": "203182",
"inchikey": "ASDOKGIIKXGMNB-UHFFFAOYSA-N",
"display_name": "HYDROXYZINE PAMOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "0555-0324_c307ca43-d41f-401b-bd15-0c753eca86e5",
"productndc": "0555-0324",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "088488",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 100MG HYDROCHLORIDE",
"product_no": "001",
"approval_date": "Jun 15, 1984"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE PAMOATE",
"proprietary_name": "Hydroxyzine Pamoate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA088488",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Pamoate",
"start_marketing_date": "19840701",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N05BB01.
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