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United States · US · US:71205-558_bff75226-d194-4d64-bcbb-d7d79f5d230e
hydroxyzine pamoate
Orange BookUNIISPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712055583030 CAPSULE in 1 BOTTLE (71205-558-30)
- ndc11712055586060 CAPSULE in 1 BOTTLE (71205-558-60)
- ndc11712055589090 CAPSULE in 1 BOTTLE (71205-558-90)
Annotations
UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A087479
AB
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": "71205-558_bff75226-d194-4d64-bcbb-d7d79f5d230e",
"productndc": "71205-558",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "087479",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG HYDROCHLORIDE",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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": "ANDA087479",
"marketing_category": "ANDA",
"nonproprietary_name": "hydroxyzine pamoate",
"start_marketing_date": "19811214",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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