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United States · US · US:50090-4385_ee21822e-a146-4f65-beaf-d10c79474f44
hydroxyzine pamoate
Orange BookUNIISPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11500904385050 CAPSULE in 1 BOTTLE (50090-4385-0)
- ndc11500904385220 CAPSULE in 1 BOTTLE (50090-4385-2)
- ndc11500904385530 CAPSULE in 1 BOTTLE (50090-4385-5)
Annotations
UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A201507
ABAB
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": "50090-4385_ee21822e-a146-4f65-beaf-d10c79474f44",
"productndc": "50090-4385",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "201507",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG HYDROCHLORIDE",
"product_no": "001",
"approval_date": "Jun 3, 2013"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG HYDROCHLORIDE",
"product_no": "002",
"approval_date": "Jun 3, 2013"
}
],
"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": "ANDA201507",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine pamoate",
"start_marketing_date": "20130603",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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