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United States · US · US:70518-1504_4911a104-b4e6-dabd-e063-6394a90a641a
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 · 4
- ndc11705181504030 CAPSULE in 1 BLISTER PACK (70518-1504-0)
- ndc11705181504160 CAPSULE in 1 BLISTER PACK (70518-1504-1)
- ndc11705181504230 CAPSULE in 1 BOTTLE, PLASTIC (70518-1504-2)
- ndc117051815043100 POUCH in 1 BOX (70518-1504-3) / 1 CAPSULE in 1 POUCH (70518-1504-4)
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": "70518-1504_4911a104-b4e6-dabd-e063-6394a90a641a",
"productndc": "70518-1504",
"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": "20181008",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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