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United States · US · US:0185-0676_c94e4245-cac4-4d59-b3a3-64a09b67c2e9

Hydroxyzine pamoate

Orange BookUNIISPLATC N05BB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN05BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0185067601
    100 CAPSULE in 1 BOTTLE (0185-0676-01)
  • ndc11
    0185067605
    500 CAPSULE in 1 BOTTLE (0185-0676-05)

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": "0185-0676_c94e4245-cac4-4d59-b3a3-64a09b67c2e9",
  "productndc": "0185-0676",
  "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": "19811214",
  "active_numerator_strength": "50"
}

Related drugs

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