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United States · US · US:76420-920_2e63fa75-efcf-d9ee-e063-6394a90ab2d0
Hydroxyzine Pamoate
Orange BookUNIISPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117642092001100 CAPSULE in 1 BOTTLE (76420-920-01)
- ndc117642092005500 CAPSULE in 1 BOTTLE (76420-920-05)
- ndc11764209203030 CAPSULE in 1 BOTTLE (76420-920-30)
- ndc11764209206060 CAPSULE in 1 BOTTLE (76420-920-60)
- ndc11764209209090 CAPSULE in 1 BOTTLE (76420-920-90)
Annotations
UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A088496
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": "76420-920_2e63fa75-efcf-d9ee-e063-6394a90ab2d0",
"productndc": "76420-920",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "088496",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG 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": "ANDA088496",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine Pamoate",
"start_marketing_date": "19840701",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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