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United States · US · US:70518-3232_4e3cc8ad-a873-32bd-e063-6294a90a2026
Hydroxyzine pamoate
Orange BookUNIISPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11705183232330 CAPSULE in 1 BLISTER PACK (70518-3232-3)
- ndc117051832324100 POUCH in 1 BOX (70518-3232-4) / 1 CAPSULE in 1 POUCH (70518-3232-5)
- ndc11705183232730 CAPSULE in 1 BLISTER PACK (70518-3232-7)
Annotations
UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A086183
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": "70518-3232_4e3cc8ad-a873-32bd-e063-6294a90a2026",
"productndc": "70518-3232",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "086183",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG 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": "ANDA086183",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Pamoate",
"start_marketing_date": "20211011",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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